Rappel de produits de santé

CentriMag Extracorporeal Blood Pumping System - Motor (2019-08-22)

Starting date:
August 22, 2019
Posting date:
August 30, 2019
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-70857

Last updated: 2019-09-05

Affected Products

CentriMag Extracorporeal Blood Pumping System - Motor

Reason

Abbott is advising our customers that we have received reports of CentriMag systems experiencing motor and pump issues resulting from electromagnetic interference (EMI). Due to this EMI exposure, customers have experienced unexpected console screen blanking, low flow or no flow, and motor behavior including noise, vibration and heating have been reported at a rate of 0.45%. Investigation has identified CentriMag motors with certain serial numbers between l05333-0001 and l06608-0024 with an increased susceptibility to EMI In a small number of cases, this issue has been associated with serious injuries due to hemodynamic compromise resulting from interruption of support. This issue can be mitigated through recalibration of the motor.

Affected products

CentriMag Extracorporeal Blood Pumping System - Motor

Lot or serial number

SN's between L05333-0001 and L06608-0024

Model or catalog number

201-10002
L201-10002

Companies
Manufacturer
Thoratec Switzerland GmbH
Technoparkstrasse 1
Zürich
8005
SWITZERLAND