MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH OXYGENATORS; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number QUADROX-I ADULT

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.

Event Description

After 30 minutes blood at the gas outlet of the oxys from hmt set.Complaint no: (b)(4).

Manufacturer Narrative

Maquet cardiopulmonary gmbh was not requested the product back for investigation since the issue is known.Maquet cardiopulmonary ag is aware of similar complaints from this product.Similar product, showing a similar malfunction, has been investigated in #:703007163: leak test of the blood side was performed.A strong leak from the gas outlet was detected.No further abnormalities could be detected.A leak can be confirmed.Further investigation steps are momentarily not possible to be executed due to work safety issues in the complaint laboratory.Therefore no exact root cause could be determined.According to the risk files the increasing pressure could be caused the issue and fibers of the oxygenator could be damaged due to this.Therefore liquid leak was detected at gas outlet.This complaint is being monitored as part of the complaint data trending of maquet cardiopulmonary gmbh and further investigations and measures will be conducted in case of adverse trending.

Event Description

Complaint#: (b)(4).

• Brand Name: OXYGENATORS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8891587
• MDR Text Key: 182550008
• Report Number: 8010762-2019-00248
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K082117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: QUADROX-I ADULT
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 92252358
• Date Manufacturer Received: 09/13/2019
• Patient Sequence Number: 1