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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-HMOD30000-USA#Q
Device Problem Complete Blockage (1094)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/17/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). A follow-up medwatch will be submitted when additional information becomes available. Reference exemption # (b)(4). Device requested but not received.
 
Event Description
It was reported that 3 pediatric quadrox's clotted off. One oxygenator had an unknown lot # which was reported under mfg report # 8010762-2018-00196. Two oxygenators with lot # 70115851 will be handled under this report as complaint (b)(4). According to the territory manager that seems to be clot in oxygenator hmod 30000 due to increase of pressure drop across oxygenator. But no clots were seen by the customer. The oxygenator was exchanged during the procedure with another one. No harm to the patient was reported. Internal reference: (b)(4) - (which is related to complaint- (b)(4) reported under mfg report # 8010762-2018-00196.
 
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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 Key7560365
MDR Text Key110053524
Report Number8010762-2018-00197
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
PMA/PMN Number
K100278
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 08/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/12/2019
Device Model NumberBEQ-HMOD30000-USA#Q
Device Catalogue Number701050330
Device Lot Number70115851
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 Received05/17/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/01/2017
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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