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

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  Reason
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  Affected products

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