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

Model Number BE-HQV 34601

Device Problem Leak/Splash (1354)

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

Event Date 03/26/2021

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.Product has been requested for investigation but not received yet.

Event Description

It was reported that the venting membrane was leaking small amounts of blood during perfusion.No further problems during perfusion.No change out of oxy was needed.No harm to patient.Not a covid patient.

Manufacturer Narrative

It was reported that the venting -de airing- membrane of the oxygenator was leaking small amounts of blood during perfusion.It was decided not to change and replace the oxygenator.No harm to patient was reported.The product was investigated in the laboratory of manufacturer on 2021-09-17.Visual inspection and leak test were performed.The visual inspection of the oxygenator showed no signs of damage.The blood-side leakage test showed leakage as dripping when the luer cap is unscrewed the de-airing membrane of oxygenator, at a pressure of 1.5 bar.Based on this failure could be confirmed.Based on the investigation results, the following most probable root causes could have contribute to the leakage at de-airing membrane: inadequate stamping membrane, inadequate welding vent membrane, inadequate adhesive application and curing connectors.Device history record for lot number 70134051 was reviewed on 2021-06-09.Following tests are performed according to the basic operation procedure (bop) as a 100 % inspection: leak test after welding; pressure test heat exchanger; leak test water side; leak and flow test gas side; pressure test blood side; coating test.According to the final test results, the oxygenator with the serial# (b)(6) passed the tests as per specifications.The occurrence rate was calculated for the reported failure and product 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.

Event Description

Complaint: #(b)(4).

Event Description

Complaint: #(b)(4).

Manufacturer Narrative

The product was investigated in the laboratory of manufacturer on 2021-07-26.Visual inspection and leak test were performed.The blood-side leakage test showed leakage as dripping when the luer cap is unscrewed the de-airing membrane of oxygenator, at a pressure of 1.5 bar.Device history record for lot number 70134051 was reviewed.Following tests are performed according to the basic operation procedure (bop) as a 100 % inspection: leak test after welding, pressure test heat exchanger, leak test water side, leak and flow test gas side, pressure test blood side, coating test , according to the final test results, the oxygenator with the serial# (b)(6) passed the tests as per specifications.Production related influences are unlikely.The occurrence rate was calculated for the reported failure and product and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The root cause analysis is ongoing.

• Brand Name: OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11670648
• MDR Text Key: 246201457
• Report Number: 8010762-2021-00253
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2021
• Device Model Number: BE-HQV 34601
• Device Catalogue Number: 70103.3326
• Device Lot Number: 92271761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Date Manufacturer Received: 09/17/2021
• Patient Sequence Number: 1