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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
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/15/2021
Event Type  malfunction  
Manufacturer Narrative
It was reported that the customer noticed blood on the lower tray below the hls set. Blood seems to be slowly leaking from the venous side of the membrane oxygenator. Otherwise, everything is functioning as it should per customer. The patient is being weaned off support. The patient was ready to come off support regardless of the leak. There was no patient harm, and the patient was weaned off successfully. The patient was covid positive, so the hls disposable was disposed of. The affected product was not available for technical investigation of the manufacturer. Thus the exact root cause of the reported event could not be determined. The production records of the affected hls module (3000159544) were reviewed on 2021-11-22. Following steps are performed according to the bop with a 100 % inspection: tightness test water side, tightness test blood side, final product test. According to the final test results, the oxygenator with the serial# (b)(4) passed the tests as per specifications. No previous complaint with an associated laboratory investigation was found. No picture or video was provided. Thus the reported failure "blood leakage from venous side" could not be confirmed. However the following most probable causes of the reported failure "blood leakage from venous side" are know according to our risk assessment hls set advanced (dms# (b)(4): mechanical damage to the connector during connection, blood tubing is damaged, damaging of connectors during removing of caps. 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 the customer noticed blood on the lower tray below the hls set. Blood seems to be slowly leaking from the venous side of the membrane oxygenator. Otherwise, everything is functioning as it should per customer. The patient is being weaned off support. The patient was ready to come off support regardless of the leak. There was no patient harm, and the patient was weaned off successfully. The patient was covid positive, so the hls disposable was disposed of. 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
neue rottenburger strasse 37
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Manufacturer Contact
neue rottenburger strasse 37
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MDR Report Key12851484
MDR Text Key281130394
Report Number8010762-2021-00619
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 11/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBEQ-HLS 7050
Device Catalogue Number701052794
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Manufacturer Received11/15/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage Unkown

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