Welcome to ARTERY.
The purpose of ART is to promote the field of work shared by technicians, technologists, engineers, scientists and other members of the multi-professional team working within the sphere of Renal Technology. The Association has over 200 members and are represented in many Renal Clinics throughout the United Kingdom. Among its members are employees of the National Health Service and private sectors.
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Latest Website Additions
Renal related alerts and recalls for drugs and medical devices
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
NxStage Medical, Inc. is voluntarily recalling certain lots of Dialysate Sacks that may contain endotoxin levels which have been confirmed to exceed the ISO quality standard for standard dialysate fluid of 0.5 EU/ml when used to prepare a dialysate batch with the PureFlow™ SL.
NxStage Medical, Inc. was made aware of the issue through customer complaints indicating elevated endotoxin levels identified through routine dialysate testing. There have been no adverse health consequences or medical interventions reported.
Issued: 29 January 2018
MHRA has published guidance on the importance of applying human factors to medical devices, so they are designed and optimised to minimise patient and user safety risks.
This guidance is intended for manufacturers, developers and notified bodies to highlight the important influence human factors have on patient safety. The advice is also relevant to device components of drug-device combination products that are regulated as medicines.
Issued: 19 September 2017
Baxter has received reports of device operators failing to adhere to the instructions for use pertaining to the safe unloading of disposable sets from the Prismaflex Control Unit.
These steps are required to safely disconnect the patient before proceeding to unload the filter set after treatment. If not followed, severe blood loss may occur with a potentially fatal outcome.
Issued: 11 March 2017
Haemofiltration machine: all Prismaflex systems installed with software version 6.10 – risk of under-infusion of anticoagulant
Manufactured by Baxter – the software fails to save the syringe type and size in service and custom modes, and so reverts to default settings.
Issued: 11 July 2017
BELLCO S.r.l.: Formula, Formula Plus, Formula 2000, Formula 2000 Plus, Formula Therapy, Formula Domus
This is an update to Medtronic’s October, 2016 notification titled “Urgent Field Safety Notice – Formula®
Hemodialysis Machines” (the “Notice”) describing thermal events that led to fire (Attachment A). Please
refer to the Section(s) applicable to the Formula machine configuration in your facility.
Issued: 05 January 2017