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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 BE-HLS 7050 #SHLS SET ADVANCED 7.0
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/30/2022
Event Type  malfunction  
Manufacturer Narrative
The investigation is ongoing. Further information has been requested but has not yet been received. A follow-up emdr will be submitted when additional information becomes available.
 
Event Description
The event occurred in united kingdom. It was reported that a suspected ruptured fiber in the oxygenator was noticed. The hls set was exchanged during patient treatment. No harm to any person has been reported. Complaint id: (b)(4).
 
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Brand NameHLS SET ADVANCED
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
neue rottenburger strasse 37
hechingen
Manufacturer (Section G)
JULIA KAPFENBERGER
neue rottenburger strasse 37
hechingen
Manufacturer Contact
neue rottenburger strasse 37
hechingen 
MDR Report Key14953092
MDR Text Key301200386
Report Number8010762-2022-00265
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K112360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBE-HLS 7050 #SHLS SET ADVANCED 7.0
Device Catalogue Number701069073
Device Lot Number3000215230
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/11/2022
Is the Device Single Use? Yes
Type of Device Usage Initial

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