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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NURSEL BOELENS QUADROX-ID SMALL ADULT/ADULT OXYGENATOR, CARDIOPULMONARY BYPASS

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NURSEL BOELENS QUADROX-ID SMALL ADULT/ADULT OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BEQ-HMOD70000-USA
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation of the manufacturer is still pending.
 
Event Description
After initiating ecls (extra corporal life support), customer noticed a leak in the arterial outlet of the oxygenator. It became more noticeable upon attempting to move the patient. Oxygenator was changed out and there was no negative patient impact. The product is available for investigation and will be returned to the manufacturer. Complaint id: (b)(4).
 
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Brand NameQUADROX-ID SMALL ADULT/ADULT
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 Key11453408
MDR Text Key239749980
Report Number8010762-2021-00172
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 06/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBEQ-HMOD70000-USA
Device Catalogue Number70106.7859
Device Lot Number70140852
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received06/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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