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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SET; TUBING, PUMP, CARDIOPULMONARY BYPASS
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MAQUET CARDIOPULMONARY GMBH TUBING SET; TUBING, PUMP, CARDIOPULMONARY BYPASS Back to Search Results
Model Number HQV 69001
Device Problem Increase in Pressure (1491)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2022
Event Type  malfunction  
Manufacturer Narrative
A follow up medwatch will be submitted when further information becomes available.
 
Event Description
It was reported that there was high membrane pressure within the oxygenator.The failure was detected after 2 minutes of cec.The entire cec circuit was changed and the operation then proceeded under satisfactory conditions with circuit pressures as usual.The patient is currently in intensive care but his neurological prognosis is uncertain.
 
Event Description
(b)(4).
 
Manufacturer Narrative
It was reported that there was high membrane pressure within the oxygenator.The failure was detected after 2 minutes of cec.The entire cec circuit was changed and the operation then proceeded under satisfactory conditions with circuit pressures as usual.No harm to any person has been reported.The product was investigated at the manufacturer laboratory, which was completed on 2022-05-24.The sample was already cleaned by customer and only small amounts of blood residues have been found.Visual control was performed and it shows that there is not any damage on the product.Leak test was performed.During blood side leak test, a leak was occurred on vent tap.However, after closing the vent tap, there was no further leak detected.This leak was not initially reported by the customer.Therefore, it could be conclude that the leak at the vent tap may have been caused by external cleaning or by transport in an unsuitable way.The tightness test was performed, and there could not be found any abnormalities.An increase in pressure in the oxygenator could not be confirmed.The reason of the pressure increase cannot be reproduced.The most probable root cause of pressure increase has been found as clots in the oxygenator, however only small amounts of blood residues has been found during sample investigation since the oxygenator was cleaned by customer.Clots in the oxygenator could be the reason of clogging and the clogged oxygenator will cause to pressure increase during treatment.Based on the test results, failure could not be confirmed.The production records of the affected oxygenator were reviewed on 2022-05-30.Following tests are performed 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 test as per specifications.Production related influences can be excluded.The production history record (dhr) of the affected hqv 69001#pack adult complete with lot# 3000181180 was reviewed on 2022-03-01.According to the dhr results, the product hqv 69001#pack adult complete passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.Thus production related influences are unlikely.Based on the investigation results, the most probable root cause has been found as: -clotting in the oxygenator.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.
 
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Brand Name
TUBING SET
Type of Device
TUBING, PUMP, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
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hechingen
Manufacturer (Section G)
JULIA KAPFENBERGER
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Manufacturer Contact
neue rottenburger strasse 37
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MDR Report Key13585660
MDR Text Key286043568
Report Number8010762-2022-00062
Device Sequence Number1
Product Code DWE
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K053025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/03/2022
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 Date07/06/2023
Device Model NumberHQV 69001
Device Catalogue Number701041726
Device Lot Number3000181180
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/15/2022
Initial Date FDA Received02/23/2022
Supplement Dates Manufacturer Received05/24/2022
Supplement Dates FDA Received06/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/06/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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