PrisMax Control Unit (2020-03-30)

Starting date:
March 30, 2020
Posting date:
April 8, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-72695

Last updated:

Affected Products

PrisMax Control Unit

Reason

Manufacturer received questions from clinicians exploring modifying their use of Prismax Control Units, in order to minimize exposure to COVID-19-positive patients. For example, clinicians may be using multiple extension lines to extend the length of the tubing set to allow placement of a Prismax Control Init outside of the patient's room. As per manufacturer, several significant risks could arise with this practice. To mitigate these risks, manufacturer is recommending following the setup instructions in the graphical user interface, as well as the warnings from the prismax operators  manual. Failure to do so could result in serious patient harm.

Affected products

PrisMax Control Unit

Lot or serial number

All lots.

Model or catalog number

955558

Companies
Manufacturer
Baxter Healthcare SA
PO BOX 8010
Zurich
8010
SWITZERLAND