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Health product recall

Heater-Cooler Units

Starting date:
September 9, 2016
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-60432

Affected Products

  1. Heater-Cooler Unit HCU 20
  2. Heater-Cooler Unit HCU 30
  3. Heater Unit HU 35
  4. Heater-Cooler Unit HCU 40

Reason

Maquet Cardiopulmonary ("MCP") as well as European Health Authorities have received reports confirming the presence of mycobacterial contamination (and other bacterial contamination) in the system water of heater-cooler devices, used during short-duration cardiopulmonary bypass procedures to warm or cool a patient. Although the water in the heater-cooler unit circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or transmit bacteria through the air (aerosolize) via the device's exhaust vent into the environment and to the patient. MCP has confirmed that Maquet Heater Cooler units may become contaminated with various strains of bacteria that also include mycobacteria species. However, there have been no reported adverse events, diseases or illnesses associated with mycobacteria contaminations. Maquet has not received any reports of patient mycobacteria infections resulting from surgery involving heater cooler units. MCP has determined that the listed product may possess the potential for bacterial contamination to occur. You are being contacted because you have been identified as a device user of one or more Maquet Heater Cooler units.

Affected products

  1. Heater-Cooler Unit HCU 20

Lot or serial number

All serial numbers.

Model or catalog number
  • HCU 20-600
  • HCU 20-601
  • HCU 20-602
  • HCU 20-603
Companies
Manufacturer
MAQUET CARDIOPULMONARY GMBH
KEHLER STR. 31, RASTATT, GERMANY, 76437
RASTATT
76437
GERMANY

B. Heater-Cooler Unit HCU 30

Lot or serial number

Tous les numéros de série.

Model or catalog number

00704629
00705501
00939001

Companies
Manufacturer
MAQUET CARDIOPULMONARY GMBH
KEHLER STR. 31, RASTATT, GERMANY, 76437
RASTATT
76437
GERMANY

C. Heater Unit HU 35

Lot or serial number

All serial numbers.

Model or catalog number

70104.909

Companies
Manufacturer
MAQUET CARDIOPULMONARY GMBH
KEHLER STR. 31, RASTATT, GERMANY, 76437
RASTATT
76437
GERMANY

D. Heater-Cooler Unit HCU 40

Lot or serial number

All serial numbers.

Model or catalog number

70104.4054 (200-240V)
70105.4917 (110-120V)

Companies
Manufacturer
MAQUET CARDIOPULMONARY GMBH
KEHLER STR. 31, RASTATT, GERMANY, 76437
RASTATT
76437
GERMANY

Date modified: