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Renal related alerts and recalls for drugs and medical devices
WRO 300H Water Purification System 
Baxter Healthcare Limited has identified that power supply code K80732001 was installed on certain WRO 300H Water Purification System devices (product code 955686) instead of power supply code K79786001.

Issued: 14 September 2020
AquaC UNO H – Risk of defective crimp connection on the protective conductor
During regular quality inspections within Fresenius Medical Care of AquaC UNO H devices we discovered incorrectly crimped connectors on the main protective earth conductor.

Issued: 28 August 2020
COVID-19 All haemofiltration systems including machines and accessories - serious risks if users don't follow manufacturer's instructions for set up.  
All manufacturers – there have been reports of off-label modifications to haemofiltration systems when treating Covid-19 patients leading to serious injury and death.
Issued: 10 April 2020
​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
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
​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
​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
​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
​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
​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
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
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