MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-ID SMALL ADULT/ADULT; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number HMOD 70000-USA

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2021

Event Type  malfunction  

Event Description

It was reported that a patient on veno venous ecmo (extra corporeal membrane oxygenation) experienced a membrane leak from the gas outlet port of the oxygenator about 10 minutes into the ecmo run.The patient was not in imminent danger but the oxygenator was exchanged before patient left the or.The changeout was uneventful.No harm was reported.Complaint id: (b)(4).

Manufacturer Narrative

The investigation of the manufacturer is ongoing.

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that a patient on veno venous ecmo (extra corporeal membrane oxygenation) experienced a membrane leak from the gas outlet port of the oxygenator about 10 minutes into the ecmo run.The patient was not in imminent danger but the oxygenator was exchanged before patient left the or.The changeout was uneventful.No harm was reported.The affected product was technically investigated at the getinge laboratory.During priming of the product no leakages were detected.Thereupon a tightness test of the blood and water side of the oxygenator was performed, no malfunction was detected.Thereupon the product was connected to a heater cooler unit were a pressure drop was observed, but also after test duration of 6 hours no water leakage from the gas outlet port was detected.Additionaly compressed air was passed through the oxygenator whereby some water drops did flow out of the gas outlet port of the product.Hereby the reported failure "membrane leak" could be confirmed.Most probable the reported failure was caused by a leakage between the blood side and water side of the product.The source of the leakage could not be determined.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿ s trending program and additional investigations or corrections will be implemented in case of adverse trending.

• Brand Name: QUADROX-ID SMALL ADULT/ADULT
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 12859534
• MDR Text Key: 281130121
• Report Number: 8010762-2021-00623
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2023
• Device Model Number: HMOD 70000-USA
• Device Catalogue Number: 701067840
• Device Lot Number: 3000179589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 11/23/2021
• Supplement Dates Manufacturer Received: 03/08/2022
• Supplement Dates FDA Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1