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

Model Number HQV 13122#QUADROX MEMBRANE SET

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

Investigation is still ongoing.A follow-up medwatch will be submitted when further information becomes available.

Event Description

It was reported that there is leak at between the blood circuit and the water circuit at the oxygenator.No harm or death was reported.Complaint : # (b)(4).

Event Description

Complaint : #(b)(4).

Manufacturer Narrative

It was reported that there is leak at between the blood circuit and the water circuit at the oxygenator.No harm or death was reported.The product was investigated in the laboratory of manufacturer on 2021-10-17.Leak test on blood side was performed and a leak above the de-airing (vent) valve was detected.The leak was occurred due to a crack at this point.The test on the water side showed no pressure drop which means that this test was passed.It was reported that leakage was at between the blood circuit and the water circuit at the oxygenator.However, a leakage at the de-airing valve was found.Based on this the reported failure leakage could be confirmed.The production records of the affected quadrox-i module (dms# 3123503, 3134971) were reviewed on 2021-10-20.Following steps are performed according to the basic operation procedure with a 100 % inspection: gluing de-airing connector, tightness test, pressure test, final product 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 to have contributed to the reported failure.The information obtained so far in this investigation would confirm that the device met its specification at the time of manufacturing and therefore all damages found on the product are due to excessive or inadequate external physical force that was exerted on the product after the release.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.

• Brand Name: TUBING SET
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 12352624
• MDR Text Key: 267619780
• Report Number: 8010762-2021-00469
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2023
• Device Model Number: HQV 13122#QUADROX MEMBRANE SET
• Device Catalogue Number: 701046406
• Device Lot Number: 3000165075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Date Manufacturer Received: 10/07/2021
• Patient Sequence Number: 1