Custom Pack with Softline, Quadrox-i Neonatal Oxygenator with Integrated Hardshell Reservoir (2019-05-12)

Starting date:

May 12, 2019

Posting date:

May 24, 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-70023

Last updated: 2019-05-24

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  Reason
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  Affected products

Affected Products

1. Custom Pack with Softline
2. Quadrox-i Neonatal Oxygenator with Integrated Hardshell Reservoir

Reason

Maquet Cardiopulmonary has received complaints in relation to leakage at the QUADROX-i Neonatal blood inlet connector.

Internal investigations have revealed that the leakage only occurs if the enclosed reducing screw adapter 1/4"" x 3/16"" is screwed onto the blood inlet connector of the QUADROX-i Neonatal Oxygenator. The leakage occurs due to a non-conforming blood inlet connector that, in conjunction with the use of the screw reducing adapter 1/4"" x 3/16"", does not result in a tight connectoradapter connection. The combination of the reducing screw adapter 1/4"" x 3/16"" with the blood outlet connector or the use of the blood inlet connector directly to tubing does not exhibit any leakage.

Affected products