Quart Arterial Filter (2019-08-29)

Starting date:

August 29, 2019

Posting date:

September 6, 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-70913

Last updated: 2019-09-06

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  Reason
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  Affected products

Affected Products

Quart Arterial Filter

Reason

Maquet cardiopulmonary has determined that the sterile barrier system of the Quart Arterial Filter may be compromised during transportation. During verification testing of transportation simulation, the integrity of the sterile packaging of one sample of 48 tested resulted in a damaged sterile barrier system of the product. Exposure to a non-sterile or potentially non-sterile medical device may result in infection-causing inflammatory like syndromes thereby deteriorating the clinical state of the patient. Additionally, infection may occur if the device is connected to the central circulatory system. Individuals undergoing extracorporeal circulation usually develop inflammatory response due to the fact that human blood cells are exposed to foreign surface with a release of inflammatory mediators as the consequence. The most severe form is called systemic inflammatory response syndrome (SIRS).  Maquet Cardiopulmonary has not received any complaints associated with damage to the sterile barrier system or to serious injuries or death due to damage to the sterile barrier.

Affected products