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Health product recall

S5 Mast Mounted Roller Pumps (MRP) 85 (2014-07-09)

Starting date:
July 9, 2014
Posting date:
July 22, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-40585

Recalled Products

S5 Mast Mounted Roller Pumps (MRP) 85 

Reason

Sorin has become aware of an increased trend in reports of "fault in motor controller (433)" alarm message events with certain mast roller pumps (MRP) 85 (product code 10-88-60) manufactured between October 6, 2011 and August 20, 2013. The failure occurs following an intended pump stop. The MRP stops and provides a visual and audible alarm on the system panel. The alarm can be cleared by pressing the reset button and the pump restarted by turning the setting knob. All complaints are related to specific HME motor control circuit boards (product code 90-305-700).

Affected products

S5 Mast Mounted Roller Pumps (MRP) 85 

Lot or serial number
  • 50E50783
  • 50E50784
  • 50E50797
  • 50E50798
  • 50E50799
  • 50E50800
  • 50E50969
  • 50E50970
  • 50E50973
  • 50E50974
  • HME LOT 12070074
Model or catalog number

50-80-62

Companies
Manufacturer
Sorin Group Deutschland GmbH
Linberghstrasse 25
Munich, Germany, 80939