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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0 OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY GMBH BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0 OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number HLS SET ADVANCED 7.0
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2021
Event Type  malfunction  
Manufacturer Narrative
Return of product was requested but not yet received. A follow-up emdr will be submitted when additional information becomes available.
 
Event Description
The customer reported that an hls set was leaking at the arterial pressure sensor/arterial temperature sensor during patient treatment. The hls set was exchanged. There was no harm reported. Complaint id: (b)(4).
 
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Brand NameBEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
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hechingen
Manufacturer (Section G)
JULIA KAPFENBERGER
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Manufacturer Contact
neue rottenburger strasse 37
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MDR Report Key12299050
MDR Text Key265758375
Report Number8010762-2021-00439
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/23/2022
Device Model NumberHLS SET ADVANCED 7.0
Device Catalogue Number701052794
Device Lot Number3000159189
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/23/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown

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