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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY GMBH TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number HQV 69400
Device Problem Increase in Pressure (1491)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/11/2021
Event Type  malfunction  
Manufacturer Narrative
A follow-up medwatch will be submitted when further information becomes available.
 
Event Description
It was reported that a high delta p is noted with the oxygenator. It was noted during patient use. The oxygenator was not replaced however the perfusionists had to keep higher rotation to obtain a normal flow. No harm or death was reported. Complaint: #(b)(4).
 
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Brand NameTUBING SET
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 Key12646483
MDR Text Key276842457
Report Number8010762-2021-00559
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K132829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHQV 69400
Device Catalogue Number701042436
Device Lot Number3000177702
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2021
Is the Device Single Use? Yes
Type of Device Usage

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