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Renal related alerts and recalls for drugs and medical devices
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Dialog+ haemodialysis machines with software versions 9.xx (excluding versions 9.18, 9.1A, 9.1B) – software and hardware upgrade required
Manufactured by B. Braun Avitum AG – Malfunction of the temperature sensor can result in temperature of the dialysis fluid to be more than ±1°C outside the programmed values, which can lead to inadequate treatment.
Issued: 26 June 2019
Manufactured by B. Braun Avitum AG – Malfunction of the temperature sensor can result in temperature of the dialysis fluid to be more than ±1°C outside the programmed values, which can lead to inadequate treatment.
Issued: 26 June 2019
Fresenius 5008/5008S haemodialysis machines - low risk of inadequate fluid removal during treatment
Manufactured by Fresenius Medical – inadequate ultrafiltration can occur due to sudden failure of the ultrafiltration (UF) pump.
Issued: 29 March 2019
Manufactured by Fresenius Medical – inadequate ultrafiltration can occur due to sudden failure of the ultrafiltration (UF) pump.
Issued: 29 March 2019
Gambro Ultrafilter U9000 microbial water filter – FOLLOW UP DOCUMENT.
The purpose of this communication is to inform you of a change in how Baxter is resetting the monitor counters on AK96 and AK98 v1 machines and to provide examples of weekly disinfection programs on Baxter dialysis machines.
Issued: 25 March 2019
The purpose of this communication is to inform you of a change in how Baxter is resetting the monitor counters on AK96 and AK98 v1 machines and to provide examples of weekly disinfection programs on Baxter dialysis machines.
Issued: 25 March 2019
Baxter Healthcare will be implementing design improvements in the CWP 800 (Central Water Plant) systems and Clinic Panels in order to make them compliant with the International Electrotechnical Commission (IEC) standards
This issue does not have the potential to lead to adverse health consequences and there have been no associated adverse events reported.
Issued: 16 November 2018
This issue does not have the potential to lead to adverse health consequences and there have been no associated adverse events reported.
Issued: 16 November 2018
Potential for excessive fluid loss on low weight loss or other sensitive patients
Baxter is communicating important safety information regarding the potential for AK 98 Hemodialysis Devices to generate excessive ultrafiltration (UF) in certain situations where treatment-related alarms occur, or where there is an ultrafilter leak.
Issued: 25 September 2018
Baxter is communicating important safety information regarding the potential for AK 98 Hemodialysis Devices to generate excessive ultrafiltration (UF) in certain situations where treatment-related alarms occur, or where there is an ultrafilter leak.
Issued: 25 September 2018
Novaline haemodialysis bloodlines used with Baxter/Gambro haemodialysis machines – Recall of specific products due to various problems encountered during clinical use (MDA/2018/025R)
Manufactured by Vital Healthcare Sdn for distribution by Baxter Healthcare Ltd – specific product codes manufactured in 2017 have functional and assembly issues which may lead to air entering the system, blood loss, clotting and delays in treatment.
Issued: 11 July 2018
Manufactured by Vital Healthcare Sdn for distribution by Baxter Healthcare Ltd – specific product codes manufactured in 2017 have functional and assembly issues which may lead to air entering the system, blood loss, clotting and delays in treatment.
Issued: 11 July 2018
Gambro Ultrafilter U9000 microbial water filter – updated instructions due to leaks during use resulting in risk of hypovolemia.
Manufactured by Baxter Healthcare – undetected leaks may occur during use after repeated disinfection cycles causing hypovolemia
Issued: May 2018
Manufactured by Baxter Healthcare – undetected leaks may occur during use after repeated disinfection cycles causing hypovolemia
Issued: May 2018
Vital Healthcare: Tubing Sets for Hemodialysis / NovaLine®
Dialysis, blood lines: BL 208 / BL 207 / BL 211 SN / BL 200 HDF / BL 245
Vital Healthcare has identified the possibility of abnormal device behaviors of the NovaLine® Tubing Sets for Hemodialysis listed above.
Issued: April 2018
Dialysis, blood lines: BL 208 / BL 207 / BL 211 SN / BL 200 HDF / BL 245
Vital Healthcare has identified the possibility of abnormal device behaviors of the NovaLine® Tubing Sets for Hemodialysis listed above.
Issued: April 2018
