QUADROX-I NEONATAL OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR (2021-05-12)

Starting date:

May 12, 2021

Posting date:

May 20, 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-75637

Last updated:
2021-05-20

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  Reason
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  Affected products

Affected Products 

QUADROX-I NEONATAL OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR

Reason

During design verification testing of Neonatal VKMO's and VHK's a potential impairment of the sterile package of the accessory part ""tight caps"" was identified. The exposure of either the blood path or sterile (operative) field to nonsterile tight caps may cause none, some, or all of the following immediate and/or long-range health consequences (injuries or illnesses):

• Exposure of the sterile (operative) field to an unsterile product which could compromise the entire surgical field.

• Exposure of a patient's vascular system to an unsterile product resulting in inflammation and/or infection.

• Sepsis due the unmitigated and unknown propagation of an infection to other regions of the corpus.

Maquet Cardiopulmonary has not received any complaints or reports of adverse events due to damage to the sterile barrier system of tight caps.

Affected products