Maquet Life Support Set and associated products (2015-12-07)

Starting date:

December 7, 2015

Posting date:

June 13, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-58824

• 
  Reason
• 
  Affected products

Affected products

1. PERMANENT LIFE SUPPORT SET
2. QUADROX-ID ADULT OXYGENATOR (WITH BIOLINE)
3. QUADROX-ID ADULT OXYGENATOR (WITH SOFTLINE)
4. CARDIOHELP HLS DISPOSABLE SET
5. HLS SET ADVANCED 5.0/7.0 WITH BIOLINE COATING
6. PERFUSION SET WITH BIOLINE COATING

Reason

In December 2014 Maquet Cardiopulmonary notified you via DYR 91 (FSN 2014-12-11) of the increased incidence of blood leakage from the gas outlet connector of the QUADROX-iD Adult and Small Adult products, including the HLS and PLS sets that contain related oxygenators of this product family.  The increased leakage was due to a separation of a small number of the internal fibers from the polyurethane casting in the oxygenator.  This separation resulted in the blood leakage that was the subject of the field safety notice. Since the release of this notification, we have been able to confirm the possible root cause that was described in the notification.  Additionally, we have implemented and validated the necessary corrections that return the products to their original performance specifications. The correction necessary was the implementation of additional process controls during the production process of these fibers at our raw material supplier. The fibers produced under these increased process controls have now been delivered to Maquet Cardiopulmonary and used on the production of the finished oxygenator products.

Affected products