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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY GMBH QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BEQ-HMOD30000-USA#QUADROX-ID PÄD.O.FILT
Device Problem Coagulation in Device or Device Ingredient (1096)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/31/2019
Event Type  malfunction  
Manufacturer Narrative
A follow up medwatch will be submitted when additional information becomes available.
 
Event Description
Customer reported clogged oxygenator inlet. Abnormally high delta p pressures were noted upon initiation. Number continued to climb higher/faster than normal. Had to switch to a different pedi quadrox-id. (b)(4).
 
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Brand NameQUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING
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 Key9590170
MDR Text Key196070498
Report Number8010762-2020-00017
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
PMA/PMN Number
K132829
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
Report Date 03/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/22/2021
Device Model NumberBEQ-HMOD30000-USA#QUADROX-ID PÄD.O.FILT
Device Catalogue Number701050330
Device Lot Number70132166
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/23/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

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