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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 VKMO 11000
Device Problems Occlusion Within Device (1423); No Flow (2991)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/10/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The product was requested for investigation, but not yet received. The incident investigation of the manufacturer is still pending. A supplemental medwatch will be submitted when further information becomes available.
 
Event Description
According to the customer: 'there was block inside the oxygenator, the blood could not go through the oxygenator. Primed with heparin and act was ok. ' (b)(4).
 
Manufacturer Narrative
The sample was not available for return as it had been discarded and therefore a full investigation could not be completed. Based on available information the failure could not be confirmed and a root cause could not be determined. A dhr review was performed and the investigation found no abnormalities and all the controls were completed in accordance with the process control form. 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. Please note this is the final report.
 
Event Description
(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 Key6085813
MDR Text Key59846037
Report Number8010762-2016-00665
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K102464
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 06/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/01/2017
Device Model NumberVKMO 11000
Device Catalogue Number701049279
Device Lot Number92171754
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 Received06/08/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/01/2015
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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