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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NURSEL BOELENS TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS

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NURSEL BOELENS TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number HLS SET
Device Problem Improper Flow or Infusion (2954)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation of the manufacturer is still pending.
 
Event Description
The following information was provided to maquet cardiopulmonary gmbh: oxygenator closed acutely after three days. No other information was provided at this time.
 
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Brand NameTUBING SET
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section G)
NURSEL BOELENS
maquet cardiopulmonary ag
kehler strasse 31
rastatt 76437
GM 76437
Manufacturer Contact
maquet cardiopulmonary ag
kehler strasse 31
rastatt 76437
4972229321
MDR Report Key10917388
MDR Text Key218689539
Report Number8010762-2020-00406
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K102726
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHLS SET
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received12/16/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

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