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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 ADULT (VKMO)
Device Problems Fluid Leak (1250); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/05/2020
Event Type  malfunction  
Manufacturer Narrative
A follow-up medwatch will be submitted when additional information becomes available.
 
Event Description
During the use of the product, the shell beside the luer connector leaks blood. The amount of bleeding is small, about 10 drops per minute. Replace the product and complete the operation. There was no injury to the patient. Complaint: (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 Key9751612
MDR Text Key204925100
Report Number8010762-2020-00086
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeCH
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 02/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberQUADROX-I ADULT (VKMO)
Device Catalogue NumberUNKNOWN
Device Lot Number70127294
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 Received04/05/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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