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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#HLS SET ADVANCED 7.0
Device Problem Noise, Audible (3273)
Patient Problem Death (1802)
Event Date 02/11/2021
Event Type  Death  
Manufacturer Narrative
Further information (patient data, perfusion protocol) were requested from the customer and are still pending. A follow-up emdr will be submitted when additional information becomes available.
 
Event Description
The customer reported that they had a covid-ecmo patient that has been on the same circuit for 45 days and the last couple days the hls set has been making a whine sound and has gotten louder. On (b)(6) 2021 it was reported that the family of the patient decided that the therapy was discontinued due to no progress of improvement over the 68 days of treatment. Patient expired. 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 Key11338840
MDR Text Key232221366
Report Number3008355164-2021-00003
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
Device Catalogue Number701052794
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/14/2021
Distributor Facility Aware Date03/25/2021
Event Location Hospital
Date Report to Manufacturer04/14/2021
Date Manufacturer Received03/25/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 02/17/2021 Patient Sequence Number: 1
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