Artis Dialysis System Equipped with SW 8.09.12 & 8.09.13 (2015-01-23)

Starting date:

January 23, 2015

Posting date:

February 16, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-43711

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  Reason
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  Affected products

Recalled Products

A) Artis Dialysis System Equipped with SW 8.09.12 & 8.09.13

Reason

Gambro is reminding users of the importance of following the instructions in the operating manual when alarm 642 "arterial chamber, level adjustment required" occurs, which indicates low blood level in the arterial chamber. Gambro has become aware of events where the instructions have not been followed and this may deactivate the alarm mechanism. The manual provides instructions on how to increase the blood level, and advises that if the reset button is pressed without adjusting the blood level, the alarm will no longer be triggered during the remaining treatment time. Performing the treatment with blood level too low in the arterial chamber may result in microbubbles smaller than 20 micro litres reaching the patient.

Affected products