CS300, CS100 and CS100i Intra Aortic Balloon Pumps (2017-06-20)

Starting date:

June 20, 2017

Posting date:

July 17, 2017

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-63968

• 
  Reason
• 
  Affected products

Affected Products

A. CS300 Intra Aortic Balloon Pump

B. CS100 Intra Aortic Balloon Pump

C. CS100i Intra Aortic Balloon Pump

Reason

Maquet/Getinge has received a complaint involving a CS300 IABP that did not pump due to an electrical test failure code #58 (power up vent tests fail), maintenance code #3, and an autofill failure, which has been associated to a patient death due to the failure of the device to initiate therapy. An electrical test failure code #58 is caused by a solenoid valve requiring more power than the solenoid driver board can deliver to open the valve. The lack of power prevents the coil from moving the plunger causing the valve not to open. This is recognized by the system as an electrical test failure code #58 upon powering on the IAB. Units distributed after December 11, 2013 are not affected by the field correction.

Affected products