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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-ID SMALL ADULT/ADULT
Device Problem Failure to Prime (1492)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A supplemental medwatch will be submitted after new information becomes available.
 
Event Description
Facility user medwatch report 0533050000-2020-8066 was received may 27 2020. Perfusion service requested to troubleshoot ecmo circuit and micro-air on arterial side of connector to the arterial filter. 3-4 small bubbles found. Circuit was vba'd and air was walked back to the bridge and floated into the bridge and then venous line. Flow established and no further air was noted. Patient maintained adequate perfusion during the time off support. Unknown source of air. Date of event noted as (b)(6) 2020. No specific day is noted on the facility medwatch report. 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 Key10117564
MDR Text Key203305715
Report Number8010762-2020-00187
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
PMA/PMN Number
K101153
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 07/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberQUADROX-ID SMALL ADULT/ADULT
Device Catalogue Number701067840
Device Lot Number70136692
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 Received06/26/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/24/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

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