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U.S. Department of Health and Human Services

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

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MAQUET CARDIOPULMONARY GMBH OXYGENATORS OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number QUADROX-I PEDIATRIC (VKMO) W/ FILTER
Device Problems Fluid Leak (1250); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/07/2020
Event Type  malfunction  
Event Description
According to the customer, 'during pediatric open heart surgery, while using the quadrox ventilation lung vkmo-31000, there was a blood leak around the root of the connector on the blood sending side. The operation was completed without any blood leaks, but the cause was investigated and reported. ' (b)(4).
 
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Brand NameOXYGENATORS
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 Key9617229
MDR Text Key190536072
Report Number8010762-2020-00030
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/12/2020
Device Model NumberQUADROX-I PEDIATRIC (VKMO) W/ FILTER
Device Catalogue Number70106.3849
Device Lot Number92250720
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/13/2018
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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