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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SET; OXYGENATOR, CARDIOPULMONARY BYPASS
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MAQUET CARDIOPULMONARY GMBH TUBING SET; OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number HQV 69400
Device Problem Increase in Pressure (1491)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/11/2021
Event Type  malfunction  
Manufacturer Narrative
A follow-up medwatch will be submitted when further information becomes available.
 
Event Description
It was reported that a high delta p is noted with the oxygenator.It was noted during patient use.The oxygenator was not replaced however the perfusionists had to keep higher rotation to obtain a normal flow.No harm or death was reported.Complaint: #(b)(4).
 
Event Description
Complaint: (b)(4).
 
Manufacturer Narrative
It was reported that a high delta p is noted with the oxygenator.It was noted during patient use.The oxygenator was not replaced however the perfusionists had to keep higher rotation to obtain a normal flow.The product was received for investigation in the laboratory of manufacturer.Visual inspection and leak test were performed.No damage or abnormalities could be found on the sample.A leakage test on the blood side was performed.At 0.2 bar a leak was detected at the luer of the blood inlet connector.Under the microscope, a crack was found on this luer.No pressure drop could be determined during the water-side leak test.No pressure increase could be observed.The leakage on the luer was not reported initially by the customer.Additionally, during visual control a 3-way valve was found to be installed on the luer-lock connector "sampling venous" by the customer.It is possible that the leakage/crack could be caused due to further handling (after oxygenator replacement) of the product or during 3-way valve installation.The reported failure could not be reproduced in the laboratory.Based on this, the product failure could not be confirmed.The production records of the affected quadrox-i module were reviewed.Following tests are performed according to the bop (basic operation procedure) 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.According to the final test results, the oxygenators with the serial# (b)(6) passed the test as per specifications.Production related influences can be excluded.The production history record (dhr) of the affected hqv 69400 with lot# 3000177702 was reviewed.According to the dhr results, the product hqv 69400 passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.Thus production related influences are unlikely.The reported failure was identified as part of current risk management file (dms #1464420, v19) and the most probable causes are associated with: blockage of oxygenator, impaired blood flow, deteriorating gas transfer, obstructed gas flow.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.
 
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Brand Name
TUBING SET
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 Key12646483
MDR Text Key276842457
Report Number8010762-2021-00559
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K132829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/18/2023
Device Model NumberHQV 69400
Device Catalogue Number701042436
Device Lot Number3000177702
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2021
Is the Device Single Use? Yes
Type of Device Usage A
Patient Sequence Number1
Patient SexPrefer Not To Disclose
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