[PDF] Data set compilation of Alerts and Recalls

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Data set compilation

of

Alerts and Recalls

Supplementary material

of the

JRC Technical Report

"Exploiting globally available safety information on medical devices to enhance EU market surveillance/vigilance" Nr AUT M DATE MFR DVC BACKGROUND/REASON ACTIONS/INSTRUCTIONS DISTRIBUTION LIST

1 AUS Alert 03/05/16

Smith &

Nephew

Pty Ltd

Birmingham Hip Product Range

Smith & Nephew is issuing an update to a

Medical Device Hazard Alert issued in 2015

to provide surgeons and hospitals with updated information on the BIRMINGHAM and the BIRMINGHAM HIP MODULAR HEAD (BHMH) System. This update contains a current summary of the information concerning the revision rates of various products in the BHR and BHMH Systems (including the Monoblock version of the

BHMH System).

Hazard Alert - The sponsor is recommending that physicians maintain their routine follow-up protocol for patients who have undergone THA. Patients who experience symptoms including pain, swelling, enlarged bursae, pseudo-tumours, tissue masses, fluid collections, or local build-up of excessive metal particles or metal hypersensitivity, may require revision surgery, with attendant risks and the potential for impaired function. The need for any additional follow-up, including the necessity for diagnostic imaging and blood tests, should be determined on a case-by-case basis following a detailed assessment of the patients' clinical circumstances.

2 AUS Recall 03/05/16

Siemens

Healthcare

Pty Ltd

ADVIA Centaur XPT Systems.

An in vitro diagnostic medical

device (IVD)

Siemens Healthcare Diagnostics has

identified an issue with the ADVIA Centaur

XPT default setting for the Daily

Maintenance Task (or Daily Cleaning

Procedure) frequency. Instruments may

have the Daily Maintenance Task frequency set to ͞As needed" instead of ͞Daily". Not performing the daily maintenance may impact any assay and can be detected through monitoring of quality control and calibration results. Recall for product correction - Siemens is advising users to not release results generated by the system if quality control results are not within acceptable ranges, and is providing instructions for users to check the daily maintenance tasks. If the frequency is set to "As Needed", users should contact Siemens in order for the frequency to be changed. All systems will be checked during the next scheduled maintenance. Siemens is not recommending a review of previously generated results. However, a review of previously generated results is at the discretion of the Laboratory Director.

3 AUS Recall 03/05/16 Ecomed

Pty Ltd

Xhibit Central Station (patient

monitoring system)

The manufacturer, Spacelabs, has received

one report of values for patient height and weight being switched when input at the

Xhibit Central Station, causing a bedside

monitor Body Surface Area (BSA) calculation to be in error. No one has been injured due to this error.

In order for the error to occur, the height

and weight values must have been entered at the Xhibit Central Station, the Cardiac

Output cable must be attached for use, and

the Cardiac Output function on the bedside monitor must be initiated. The BSA value is determined by the monitor from height and weight of the patient and is used in subsequent hemodynamic calculations such as Cardiac Index. Recall for product correction - Ecomed is providing users with work around instructions to follow as an interim measure. Affected customers will be provided with a software upgrade as a permanent correction.

The bedside monitor also contains a ͞drug

calculator" for computation of drug dose conversions by weight or other units of measure. In situations where the failure mode has occurred, this initial value will not be accurate due to the height and weight transposition.

4 AUS Recall 03/05/16

Siemens

Healthcare

Pty Ltd

ADVIA Chemistry XPT System

with software versions 1.0.3 and 1.1. An in vitro diagnostic medical device (IVD)

Siemens has identified multiple software

issues that may affect the day-to-day behaviour and/or workflow of the system.

1. All levels of QC run when only 1 is

selected in Start/Restart window

2. Changing the display name of an assay

deselects that method in its associated QC panel, therefore QC for the renamed assay will not run as part of the panel.

3. A Workstation Services restart screen

may appear under multiple scenarios, causing the user interface to be temporarily inaccessible. The user will be prompted to login once the services restart. a.Workstation services may restart if a user defined filter is created in the Test Results

Overview screen that includes the 31st day

of the month, but is run in a month that does not have 31 days. b.Workstation services may also restart when all items are removed from the

Watchlist.

4. The Chemistry XPT software does not

update assay utilisation counters for ISE tests when patient samples and QC samples are run in version v1.1. Recall for product correction - Siemens is providing users with work around instructions to follow as an interim measure. A software upgrade will be installed as a permanent correction. Users are advised to review the issues with the Medical

Director.

6 AUS Recall 05/05/16

Draeger

Medical

Australia

Pty Ltd

D-Vapor and D-Vapor 3000

Vaporisers (used in connection

with Baxter Desflurane Agent and Bottles)

Manufacturer: Draeger

Medical Australia Pty Ltd

isolated cases in which the unwanted release of evaporating agent was observed by users at the end of the filling procedure. causes for the reported issues of unwanted release of evaporating agent after filling: Recall for product correction - Baxter is advising users to adhere to the product IFU when handling the device. Recently updated Material Safety Data Sheets (MSDS) of Desflurane manufacturers recommend the wearing of safety glasses when handling these substances.

A. Non observance of the correct filling

procedure, especially with regards to the 2 to 3 seconds pause before bottle removal after filling; and

B. High friction of the drug bottle valve

inside the vaporiser opening may delay closing of the bottle valve after filling

The release of unintended evaporating

agent may lead to spraying of aerosol into face and eyes of the operator. Eye contact with volatile anaesthetics can result in serious irritation; immediate flushing of eyes and consultation of a physician is recommended.

7 AUS Recall 06/05/16

Lima

Orthopaedi

cs Australia

Pty Ltd

SMR Glenosphere Impactor

Manufacturer: Lima

Orthopaedics Australia Pty Ltd

Lima Orthopaedics has received complains

about the intra-operative breakage of the glenosphere impactors/extractors.

The breakage occurs at a location

corresponding to the threaded section which is screwed into the glenosphere before impacting the glenosphere into the metal back glenoid through the connector.

If the reported issue occurs during surgery,

it may result in a slight prolongation of the surgical time. Although unlikely, in a worst case scenario, the surgeon would be unable to remove the broken thread from the glenosphere cavity nor be able to remove and replace the glenosphere, therefore the broken tip would remain in the patient. Recall for product correction - Customers are advised to inspect stocks and quarantine the affected units prior to their return.

8 AUS Recall 06/05/16

Philips

Electronics

Australia

Ltd

MobileDiagnost wDR 2, all

software versions affected (diagnostic x-ray system)

During recent evaluations of the Philips

MobileDiagnost wDR 2, Philips has

identified a potential issue that could result in unnecessary radiation exposure to the patient under certain conditions.

1. The system may sporadically apply the

default x-ray exposure parameters for an adult (patient type͗ ͞Normal"), eǀen though the patient type ͞Newborn" was selected and is displayed in the generator control area of the Eleva User Interface. Recall for product correction - Philips is providing work around instructions for users to follow as an interim measure. A software upgrade will be implemented as a permanent correction.

2. Under certain conditions, the detector

might not be ready for examination.

Released x-ray might lead to an image with

artefacts and a retake is required. While the attachment process is running, the detector might be too short in front of the IR (Infrared) sensor and the problem of the washed out images can appear if an exposure is taken right after that.

9 AUS Recall 06/05/16

Philips

Electronics

Australia

Ltd

Ingenuity Core128 CT System

During production two different length

fasteners were found to be made of stainless steel rather than the specified alloy steel. The nonconforming fasteners may have been used to manufacture Ingenuity

CT systems. The fasteners are used to

secure sub-components of the adjustment cradle within the system gantry.

Analysis has concluded that the

nonconforming fasteners continue to meet the tensile safety factor requirements for the application. However given the material characteristics of stainless steel, these fasteners may not be re-used (re-torqued).

Since the adjustment cradle requires

periodic adjustment, it is expected that the nonconforming fasteners would require re- lifetime.

Repeated re-torqueing of the stainless steel

fasteners could introduce stresses that approach the ultimate yield strength of the fasteners. There have been no reports of injuries. Recall for product correction - Philips is advising users that a field service technician will replace the affected screws on all affected systems.

10 HC Recall 02/05/16

BECKMAN

COULTER

INDIA

PRIVATE

LIMITED

50-B, II

PHASE,

PEENYA

INDUSTRIA

DURACLONE B27

Lot or serial number: 210116

Beckman Coulter has identified that the

reagent lot identified above was inadvertently released to market despite not meeting its full product specification.

The HLA-B27 Median Fluorescence Intensity

(MDFI) of this lot is higher than lots meeting the product specification, which may lead to: (1) an indicated result in the indeterminate zone when the true result is L

BANGALOR

E INDIA in the negative range, or (2) an indicated result in the positive range when the true result is in the indeterminate zone. The issue was discovered on 16, March 21 during periodic review of our batch records.

There has been no report of death or injury

related to this defect.

11 HC Recall 02/05/16

Beckman

Coulter,

Inc.

250 S.

Kraemer

Blvd. Brea 92821

California

UNITED

STATES

GASTROCCULT 40T

Lot or serial number: More

than 10 numbers, contact manufacturer.

Beckman Coulter has confirmed an issue

where the pH test area for the Gastroccult kit may display an unexpected color for a sample at a pH 7 reading when compared to the associated section of the color comparator bar. A sample with a pH 7 may exhibit a brownish-yellow color reading instead of the expected olive green color.

The issue was first reported by a US account

in March 2015 but the issue was escalated due to trending observed in January 16.

12 HC Recall 02/05/16

Philips

Medical

Systems

(Cleveland) Inc.

595 MINER

ROAD

CLEVELAND

Ohio

UNITED

STATES

A. BRILLIANCE 40/64 SLICE CT

SYSTEM

B. BRILLIANCE ICT SYSTEM-

SYSTEM

C. BRILLIANCE ICT SP SYSTEM-

MAIN

D. INGENUITY CT SYSTEM

IMR cardiac - irregular appearance of

contrast in vessels, missing image annotation's in cct, halo artifacts, incorrect Z annotation on plan box for coronal/sagittal surviews, unintended change of acquisition timing on scan ruler, bolus tracker does not trigger as expected, system unresponsive when paused, system becomes unresponsive during timed scan, unplanned results during multi-phase pulmo series, may cause a system crash, communication errors between host computer & gantry, incorrect phase tolerance for cardiac step & shoot, error when auto ROI placement outside patient anatomy, no "go" when HR is outside of acceptable range, console unresponsive when gantry cancels scan, unable to match Z locations on prescan and

4D CT scan, pin wheel artifact using 0.67mm

slice width, tracker scan halted with fdom. (please contact manufacturer for details regarding reasons for recall)

13 HC Recall 02/05/16 Pulpdent

CorporatioOpaquer Opaquer does not have a Health Canada

license and was sold into Canada through a n 80

OAKLAND

STREET

P.O. BOX

780

WATERTO

WN 02472

Massachus

etts

UNITED

STATES

clerical error.

14 HC Recall 02/05/16

AGFA

Healthcare

N.V.

Septestraat

27

Mortsel

2640

BELGIUM

DX-D 600

There is a potential of an unsecured

mechanical detent marker of the DX-D 600 system.

15 HC Recall 02/05/16

Beckman

Coulter

Inc.

250 S.

Kraemer

Blvd. 92821

UNITED

STATES

A. UNICEL DXH 800 COULTER

CELLULAR ANALYSIS SYSTEM

B. UNICEL DXH 600 COULTER

CELLULAR ANALYSIS SYSTEM

Beckman Coulter has confirmed an issue

where the Red Blood Cell (RBC) aperture baths can contain residue in the sweep flow fittings. This residue may potentially create increased background failures, flagged results and vote outs for RBC and platelet (plt) parameters.

16 HC Recall 02/05/16

Bard Access

Systems

Inc.

605 North

5600 West

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