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: 2020-06-15
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