BEUDAMED
    FDA Adverse Event Death Summary report: N

    TUBING, PUMP, CARDIOPULMONARY BYPASS

    MDR report key: 8470871 · Received April 1, 2019

    Report

    Report Number
    8010762-2019-00085
    Event Type
    Death
    Date Received
    April 1, 2019
    Date of Event
    August 22, 2018
    Report Date
    April 29, 2019
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWE
    PMA / PMN Number
    K053025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002 IMPORTER- (B)(4). THIS INCIDENT WAS NOT REPORTED TO MAQUET LTD. SALES OR QA DEPARTMENTS BY CUSTOMER. THE HOSPITAL REPORTED THE CASE DIRECTLY TO THE AUTHORITY. MAQUET CARIDOPULMONARY GMBH WAS RECEIVED THIS REPORTING INFORMATION ON 2019-03-14 AND INITIATED THIS COMPLAINT. DEVICE HISTORY RECORD WAS REVIEWED. THERE WERE NO REFERENCES FOUND WHICH ARE INDICATING A NON-CONFORMANCE OF THE PRODUCT IN QUESTION. DURING INVESTIGATION, INFORMATION WAS RECEIVED FROM MAQUET LTD. PRODUCT MANAGER, SALES THAT THE CASE WENT COMPLETELY NORMALLY, THE PRODUCT FUNCTIONED AS PER EXPECTATION. THE CAUSE OF THE REPORTED EVENT WAS DETERMINED TO NOT BE ATTRIBUTED TO A DEVICE RELATED MALFUNCTION. BASED ON THESE RESULTS AND THE INFORMATION AVAILABLE AT THIS TIME THE SET IN QUESTION OPERATED WITHIN MCP SPECIFICATIONS. 2019-04-11. THUS THE REPORTED FAILURE COULD NOT BE CONFIRMED. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). REFERENCE EXEMPTION # E2018002.

    Description of Event or Problem · 0

    REF: (B)(4).

    Description of Event or Problem · 0

    THE INCIDENT WAS REPORTED BY USER TO (B)(6). ACCORDING TO THE (B)(6) REPORT: "DETAILS OF INJURY (TO PATIENT, CARER OR HEALTHCARE PROFESSIONAL): STROKE FOLLOWING CORONARY ARTERY BYPASS GRAFTS FOLLOWED BY DEATH 4 MONTHS LATER. AT INQUEST (B)(6) SUGGESTED MICROEMBOLI GENERATED BY ARTIFICIAL CIRCUIT MAY HAVE BEEN CAUSATIVE OF NEUROLOGICAL INJURY." REF.: # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264854 TUBING, PUMP, CARDIOPULMONARY BYPASS TUBING, PUMP, CARDIOPULMONARY BYPASS DWE MAQUET CARDIOPULMONARY GMBH HQV 51201 902235864

    Patients

    Seq Age Sex Outcome Treatment
    1 Death