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U.S. Department of Health and Human Services

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

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MAQUET CARDIOPULMONARY GMBH OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number QUADROX-I SMALL ADULT/ADULT
Device Problem Infusion or Flow Problem (2964)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2020
Event Type  malfunction  
Manufacturer Narrative
A follow-up emdr will be submitted when further information becomes available.
 
Event Description
During the extracorporeal circulation, the oxygenating module did not exchange properly. After 1h of extracorporeal circulation, the internal dp was> 150mmhg, so the staff decided to replace the oxygenator with a new unit. Complaint #: (b)(4).
 
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Brand NameOXYGENATOR
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
neue rottenburger strasse 37
hechingen
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 Key11013427
MDR Text Key222843414
Report Number8010762-2020-00439
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/18/2022
Device Model NumberQUADROX-I SMALL ADULT/ADULT
Device Catalogue Number70104.2436
Device Lot Number92280682
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/19/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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