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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED; OXYGENATOR, CARDIOPULMONARY BYPASS
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MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED; OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BEQ-HLS 7050 USA
Device Problem Failure to Deliver (2338)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/19/2022
Event Type  malfunction  
Event Description
It was reported that a disposable failure alarm occurred during priming.No forward flow after approximately 1 minute of forward flow.No patient involvement.The hls set was exchanged for another set that worked fine.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 disposable failure alarm occurred during priming.No forward flow after approximately 1 minute of forward flow.No patient involvement.The hls set was exchanged for another set that worked fine.No harm was reported.The returned product was investigated at the laboratory of the manufacturer.Conclusion visual inspection: the complaint sample does not show any damages which are potentially related to the failure described by the customer.Conclusion functionality test: the polarity check of the magnets do not show any deviation.The test shows the correct alternating arrangement of the magnets.The functionality of the centrifugal pump could be maintained over the entire speed range up to 5000 rpm/min.Over the entire speed range no abnormalities like noise, unusually flow or pressure values could be identified.The described grinding noises in lower rpm range are not uncommon and depend on the perception of the test person.From technical point of view noise formation during system start-up is possible.It is possible to stop and restart the centrifugal pump without abnormalities.Repeated installation and removal of the hls module advanced on the drive of the cardiohelp does not have an influence on the function of the centrifugal pump.The additional performed functional test with water over one hour at 0,533 bar (400 mmhg) shows constant flow over the complete testing period without deviations.Based on the performed tests it can be stated that the function of the centrifugal pump of the complaint sample is given.The failure described by the customer could not be reproduced from a technical point of view.The production records of the affected hls module (3000207510,3000202950, 3000199548,3000199549 ) were reviewed.Following tests are performed as a 100 % inspection: - gluing of sensors, - gluing of cover for temperature and pressure sensor, - flow test gas side, - functionality test hls module (sensors and pump).According to the final test results, the oxygenator with the serial# 1823796 passed the test as per specifications.Production related influences are unlikely to have contributed to the reported failure.Thus the reported failure "no forward flow" was not reproducible and was not confirmed during investigation.The exact root cause of the reported event 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.
 
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Brand Name
HLS SET ADVANCED
Type of Device
OXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
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Manufacturer (Section G)
JULIA KAPFENBERGER
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Manufacturer Contact
neue rottenburger strasse 37
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MDR Report Key14494724
MDR Text Key292575320
Report Number8010762-2022-00190
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102726
Number of Events Reported1
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 05/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/26/2022
Device Model NumberBEQ-HLS 7050 USA
Device Catalogue Number701069078
Device Lot Number3000207510
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Manufacturer Received07/05/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/26/2021
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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