Health product recall

HEATER-COOLER UNIT HCU40 (2021-08-25)

Starting date:
August 25, 2021
Posting date:
September 10, 2021
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-76405

Last updated:
2021-09-10

Affected Products

HEATER-COOLER UNIT HCU40

Reason

Cleaning and/or descaling procedures for the internal water circuits can lead to crystalline deposits in the 3-way-valve promoting corrosion and malfunctions. In case of a malfunction of the 3-way valve, the valve does not close completely. In this case, a certain amount of warm water is not circulating in the main or patient circuit. Instead this warm water is guided back to the water tank leading to an increase of the water temperature and accelerated melting of the ice block. Consequently, the available time for the user to cool down the patient is reduced.

Affected products

HEATER-COOLER UNIT HCU40

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • 70105.4054 (200-240V)
  • 70105.4917 (110-120V)
Companies
Manufacturer

Maquet Cardiopulmonary GmbH

Kehler Str. 31

Rastatt

76437

GERMANY