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U.S. Department of Health and Human Services

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

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MAQUET CARDIOPULMONARY GMBH QUADROX-ID PÄD OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BE-HMOD 30000#BE-QUADROX-ID PÄD.O.FILT.
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/13/2021
Event Type  malfunction  
Manufacturer Narrative
Further patient data and perfusion protocol were requested but not yet received. A follow-up emdr will be submitted when additional information becomes available.
 
Event Description
The customer reported that the oxygenator clotted and the oxygenation decreased during treatment. No harm to patient reported. Complaint id: (b)(4).
 
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Brand NameQUADROX-ID PÄD
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
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MDR Report Key12337816
MDR Text Key267109650
Report Number8010762-2021-00456
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
K132829
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 03/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberBE-HMOD 30000#BE-QUADROX-ID PÄD.O.FILT.
Device Catalogue Number701047041
Device Lot Number70143295
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2020
Is the Device Single Use? Yes
Type of Device Usage

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