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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 13122#QUADROX MEMBRANE SET
Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Investigation is still ongoing. A follow-up medwatch will be submitted when further information becomes available.
 
Event Description
It was reported that there is leak at between the blood circuit and the water circuit at the oxygenator. 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 Key12352624
MDR Text Key267619780
Report Number8010762-2021-00469
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K132829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHQV 13122#QUADROX MEMBRANE SET
Device Catalogue Number701046406
Device Lot Number3000165075
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/16/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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