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U.S. Department of Health and Human Services

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

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MAQUET CARDIOPULMONARY AG OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BEQ-HMOD70000-USA
Device Problems Detachment Of Device Component (1104); Fluid Leak (1250); Structural Problem (2506)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/26/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The product was requested to return for manufacturers laboratory investigation but was not yet received. A follow-up medwatch will be submitted when additional information becomes available.
 
Event Description
According to the customer: after 2 hours on ecmo, ((b)(6)-clinical perfusionist)i realized that both plasma and blood were seeping out of the cap on the re-circulation port on the post-oxygenator side of the membrane. It was not leaking from the sides of the cap, but both plasma and blood were seeping out of the top of the cap. I tried to tighten the cap but it was already on the port securely we wiped it with alcohol to clean it and places a optisite to protect and left to cap on. Eventually is clotted off and did not leak anymore. (b)(4).
 
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Brand NameOXYGENATOR, CARDIOPULMONARY BYPASS
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY AG
rastatt
GM
Manufacturer (Section G)
BERND RAKOW
maquet cardiopulmonary ag
kehler strasse 31
76437 rastatt
GM
Manufacturer Contact
maquet cardiopulmonary ag
kehler strasse 31
76437 rastatt 
4972229321
MDR Report Key7350370
MDR Text Key103020180
Report Number8010762-2018-00101
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K101153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/01/2019
Device Model NumberBEQ-HMOD70000-USA
Device Catalogue Number701053824
Device Lot Number70119586
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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