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Safety Notice 005/09

20 March 2009

Distributed to: Chief Executives Directors of Clinical Operations Directors of Clinical Governance Area Clinical Product Managers

Therapeutic Goods Administration Recalls

The established process for TGA medical device recalls/product corrections is for the manufacturer/sponsor to dispatch letters to the relevant service providers within two working days of the recall date. If affected, your health service will have received a letter from the manufacturer/sponsor advising of the recall. TGA Class I defects are potentially life threatening or could cause serious risk to health. Class II defects could cause illness or mistreatment, but are not Class I. This Safety Notice is provided to reinforce the TGA process. It contains selected Class II medical device recalls/product corrections for your implementation, if relevant.

Class I

Action required by: Directors of Clinical Governance Various absorbable sutures ARTG number Product Description 1381914 MONOCRYL* (poliglecaprone 25) Suture 141405 132034 Coated VICRYL* (polyglactin 910) Suture

Item Code Y911G J643H

Lot APZ480 AP2528

Coated VICRYL* Plus Antibacterial (polyglactin VCP105G AP2507 910) Suture (Reference: RC-2009-RN-00101-3) Date: 9/02/2009 ARTG No: 139227 Reason: Sterility of the products cannot be assured due to a failure in the sterilisation process. Lack of sterility could potentially lead to infection and other serious patient consequences. Further information: Johnson & Johnson Medical Pty Ltd, Mr Craig Bell 1800 257 210 We recommend you also inform: Directors of Nursing and Midwifery Directors of Clinical Services Directors of Imaging Directors of Pathology Edwards Swan Ganz Continuous Cardiac Output (CCO) Catheters. Product Code 139HF75, Lot number 58623753 and Product Code 744HF75, Lot number 58636668 (Reference: RC-2009-RN-00124-3) Date: 13/02/2009 ARTG No: 24478 Reason: Cardiac output measurements may become unavailable and the Vigilance monitors may display the following fault message: "Fault, CCO Catheter Verification Use Bolus Mode". Further information: Edwards Lifesciences Pty Ltd, Edwards Customer Service 1800 222 601 Arrow International 30/40/50 CC IAB Volume Connectors used for gas delivery to the 30/40/50 CC Intra-Aortic Balloon Catheters Model numbers: IAB-05830-LWS, IAB-05830-U, IAB-05840-LWS, IAB-05840-U, IAB06830-U, IAB-06840-U. Selected lot numbers (Reference: RC-2009-RN-00113-3) Date: 16/02/2009 ARTG No: 101617, 106866, 107249 Reason: A fault in the connector of the pump tubing assembly may result in the volume setting of the pump defaulting to 2.5 cc's or 5 cc's (depending on the IABP model) rather than the appropriate 30, 40, or 50 cc volume. Further information: The Mayo Group International Pty Ltd, Geoff Braid 02 8337 7942

Expert Reference Group Information provided by: Therapeutic Goods Administration

Quality and Safety Branch NSW Department of Health Tel. 02 9391 9200 Fax. 02 9391 9556 Email [email protected] Website uality/sabs/index.html

Suggested Actions by Area Health Services

1. 2. 3.

Determine if this Safety Notice is relevant for your Area Health Service. Ensure that this Safety Notice is distributed to all relevant stakeholders. Ensure that relevant areas have received letters of "actions required" from sponsors of the medical devices/products. 1 of 2 1 of 3

Safety Notice 005/09

20 March 2009

Therapeutic Goods Administration Recalls

Class II

Liko Uno, Viking S, Viking XS and LikoLight mobile lifts, Affected products, serial numbers (sequential): Uno 100 EM/EE: s/n 7090001 - 7096199 , Uno 101: s/n 10001 - 11000 , Uno 102: s/n 20001 ­ 21300, Uno 102 EM/EE/ES: s/n 30001 ­ 48099, Viking S: s/n 7300301 ­ 7301299, Viking XS: s/n 7400301 ­ 7400749, LikoLight: s/n 2500001 ­ 2505899 (Reference: RC-2009-RN-00037-3) Date: 19/01/2009 ARTG No: 133067 Reason: The actuator of the lifts has the potential to separate when the upper arm is fully extended. If this happens when a patient is being lifted the lift will fail, resulting in a patient fall. Further information: Medtec Products Australia Pty Ltd, Mr Phil Jones 03 8761 6956 Huntleigh Healthcare Birthright Birthing Beds and Hoskins Birthcare Birthing Beds All models both electric and manual (Reference: RC-2009-RN-00112-3) Date: 11/02/2009 ARTG No: 98841 Reason: The beds can become unstable and tip if patients, visitors or staff sit or kneel near the foot end of the bed Further information: Huntleigh Healthcare Pty Ltd, David Henry 08 9314 4105 Philips Big Bore CT Scanners with Software version v2.3.5.17164 or below. (Reference: RC-2009-RN-00114-3) Date: 12/02/2009 ARTG No: 98868 Reason: Under certain circumstances, if image data is interleaved or discarded, information that may be essential for isocenter positioning or proper contour placement may be missing. This may result in mistreatment of the patient. Further information: Philips Electronics Australia Ltd, Philips Customer Care Centre 1800 251 400 ADVIA® Chemistry Systems Creatinine (CREA) and Creatinine _2 (CREA_2) reagents. An in vitro diagnostic medical device (IVD) (Reference: RC-2009-RN-00106-3) Date: 12/02/2009 ARTG No: 98841 Reason: On-Board Stability for these assays without use of a reagent container is being reduced to 12 days. Reagent stored onboard beyond 12 days without reagent container inserts may exceed the maximum software calibration factor limit upon recalibration, resulting in failed calibration. Further information: Siemens Healthcare Diagnostics Pty Ltd, Sue Sterling, Product Specialist 1800 358 030 Symbia T and S series CT scanners fitted with an optional Automatic Collimator Changer. (Reference: RC-2009-RN-00119-3) Date: 13/02/2009 ARTG No: 123883 and 141951 Reason: When the automatic collimator exchanger is undergoing a collimator change operation at the launch of an acquisition workflow, patient injury may occur if the patient body extends over the end of the patient bed. Further information: Siemens Ltd, John Selakovic 1800 227 587 Stryker PainPump2 (a disposable patient-controlled analgesic infusion pump)

Part Number Description Lot Number(s)

0521-125-000 0521-155-000 0525-125-000 0525-155-000 0540-025-000 0540-050-000 0540-155-000 0540-350-000 0541-155-000


08322012, 08325012 08240012, 08280012, 08325012 08228012, 08240012, 08248012, 08259012 08236012, 08324012, 08297012 08255012, 08260012, 08311012 08239012, 08274012 08259012, 08268022, 08271012, 08273022, 08323012, 08344012 08296012, 08304012 08275012, 08276012, 08296012, 08301012, 08304012, 08254012, 08303012

(Reference: RC-2009-RN-00128-3) Date: 17/02/2009 ARTG No: 153893 Reason: The pump may potentially experience an electronic failure. The electronic failure can occur either during preparation of the unit or during patient use. Further information: Stryker Australia Pty Ltd, Local Stryker Representative 1800 803 601 2 of 3

Safety Notice 005/09

20 March 2009

Therapeutic Goods Administration Recalls

Class II (cont.)

ZOLL AED Plus Defibrillator. All serial numbers (Reference: RC-2009-RN-00127-3) Date: 19/02/2009 ARTG No: 99437 Reason: Reports received that following a long period (several years) without use, a ZOLL® AED Plus® may prompt "change batteries" during use and fail to deliver therapy Further information: Zoll Medical Australia Pty Ltd, Zoll Customer Support 1800 605 555 Unomedical Female Catheter Nelaton Product Code 011.12.020 Batch Number 1030160 (Reference: RC-2009-RN-00118-3) Date: 13/02/2009 ARTG No: 135205 Reason: Some of the primary packs have been labelled incorrectly with product code 011.060.020 (6 FG) instead of 011.02.020 (12 FG). All outer cartons have been labelled correctly. Further information: Unomedical Pty Limited, Jianhe Chen 02 9979 0808

Class I and II's For Information only-NOT in NSW

Class I Spacelabs Blease Anaesthesia Ventilator Series 700 and 900, BleaseSirius and BleaseFocus systems. Software version 9.11 (Reference: RC-2009-RN-00056-3) Date: 23/01/2009 ARTG No: 137283 Reason: In certain circumstances, apnoea and Low Minute Volume alarms on the ventilators may be inhibited. Further information: Medtel Pty Ltd, Lyndon Thomas (Product Specialist) 0407 011 458 Heartstring II Proximal Seal System Model HSK-2038 Lot 8030372 to 9012271; Model HSK-2043 Lots 8030571 to 9011671 (Reference: RC-2009-RN-00123-3) Date: 13/02/2009 ARTG No: 158121 Reason: During shelf-life aging testing a small number of devices exhibited signs of packaging damage, which may lead to compromised sterility. Further information: Maquet Australia Pty Ltd, Neville Motley 02 9680 2518 Class II GE Centricity PACS RA1000 Workstation; Software Versions : PACS 1.0CSR5 / 2.0CSR1 and all service packs (Reference: RC-2009-RN-00036-3) Date: 16/01/2009 ARTG No: 115596 Reason: Under certain conditions, use of the F12 function may cause erroneous results to be added to patient reports. Further information: GE Healthcare Australia Pty Ltd, GE Customer Care 1800 659 465 ConMed Pediatric R2 Multifunction (defibrillator) Electrodes Catalogue number 3200-1711, mislabelled labelled as 311-1721 Lot number 0810211 only Affected product is in a PINK pouch with a WHITE label. (Reference: RC-2009-RN-00102-3) Date: 17/02/2009 ARTG No: 115596 Reason: The manufacturer has identified a labelling error. Some pouches containing R2 Paediatric Multifunction Electrodes (product code 3200-1711) may be labelled in error as containing R2 ADULT Multifunction Electrodes (product code 311-1721). Further information: ConMed Linvatec Australia Pty Ltd, Ferno Australia 1800 804 647

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