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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 BE-HMOD 30000
Device Problems Occlusion Within Device (1423); No Flow (2991)
Patient Problem No Information (3190)
Event Date 09/28/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The sample was returned on (b)(6) 2017 and it was investigated in the complaints laboratory at the site in hechingen. During the rinsing of the quadrox-i pediatric, no clots were flushed out. The dhr review showed no deviations. The sample was investigated and the failure could not be confirmed. There was no evidence of a production issue, and the conclusion of the investigation is that the issue is not related to a product-related failure, and the most likely root cause would be related to a clinical or application-related issue. No systemic issue was identified from the complaint database review but the data, however, will continue to be monitored and if a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary. Due to this no further investigation or action is warranted at this time and the complaint will be closed.
 
Event Description
(b)(4).
 
Manufacturer Narrative
(b)(4). The product was requested for the manufacturers laboratory investigation. The investigation is still pending. A supplemental medwatch will be submitted when additional information becomes available.
 
Event Description
According to the surgeon, who was responsible for the surgery, a circulatory support system (ecmo) was initiated for a child, immediate postoperative for aortic arch hypoplasia correction of transposition of the great arteries. On the first day of ecmo, the machine couldn't give flow. Suspected presence of thrombus in the oxygenator membrane. The product was exchanged. (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 Key6052096
MDR Text Key246008540
Report Number8010762-2016-00642
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K100278
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 09/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/24/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/01/2016
Device Model NumberBE-HMOD 30000
Device Catalogue Number701047041
Device Lot Number70102771
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/01/2014
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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