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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 Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/10/2021
Event Type  malfunction  
Manufacturer Narrative
The affected product was not available for technical investigation of the manufacturer as it was disposed off. The exact root cause could not be determined. However, the reported failure "blood leaking from gas outlet port" was investigated in a previous complaint with the following results: during a tightness test of the hls module water was leaking out of the gas outlet port. The most probable cause of the reported leakage could be: inadequate pur potting, fiber delamination, fiber damage. Hereby blood can leak either to the outer cover plate, or between fibers and pur potting or through the oxygenating fibers self. The leaking blood collects at the lowest port of the oxygenator (gas outlet port) and therefore leads to the reported failure. Based on the above mentioned investigation results and on the picture the customer provided the reported failure "blood leaking from gas outlet port" could be confirmed. The occurrence rate regarding the above complaint is below the acceptance rate. Thus, no remedial action 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
It was reported that blood leaked from the gas outlet port of the hls module. Circuit was setup and primed the same day. Patient had been on the circuit for 6 hours before the leak was noticed upon sighing. It was left for another 6 hours before circuit was changed out. Minimal blood loss and no effect to the patient except the procedure for circuit changeout. Set was disposed of therefore unfortunately not available for return and investigation. No harm to any person was reported. Complaint id: (b)(4).
 
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Brand NameHLS SET ADVANCED
Type of DeviceOXYGENATOR, 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 Key13050997
MDR Text Key282546795
Report Number8010762-2021-00667
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
Report Date 12/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBEQ-HLS 7050 USA
Device Catalogue Number701069078
Device Lot Number3000193358
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Manufacturer Received12/13/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/17/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown

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