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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-ID PEDIATRIC OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY GMBH QUADROX-ID PEDIATRIC OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BEQ-HMOD30000-USA
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/09/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation of the manufacturer is ongoing.
 
Event Description
It was reported that a red tinged drop of condensate has exited the gas exhaust port of the pediatric quadrox id. There is no negative patient sequalae due to this event. The oxygenator was not changed out due to this event. Oxygenator continues to function as normal. Customer informed me that the oxygenator was exposed to line pressures around 320 mmhg, however the pressure drop across the membrane was approximately 20 mmhg. No harm to any person was reported. Complaint id: (b)(4).
 
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Brand NameQUADROX-ID PEDIATRIC
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 Key13041849
MDR Text Key282482604
Report Number8010762-2021-00663
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100278
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,Followup
Report Date 01/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBEQ-HMOD30000-USA
Device Catalogue Number701070397
Device Lot Number3000194747
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Manufacturer Received12/20/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/23/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown

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