BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

    MDR report key: 6736028 · Received July 24, 2017

    Report

    Report Number
    8010762-2017-00238
    Event Type
    Malfunction
    Date Received
    July 24, 2017
    Date of Event
    May 31, 2017
    Report Date
    June 15, 2018
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K943803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MAQUET MEDICAL SYSTEMS, USA(IMPORTER)SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY(B)(4). RASTATT, GERMANY. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. IMPORTER- MAQUET MEDICAL SYSTEMS USA (B)(4). CONTACT PERSON- (B)(6). FIELD SERVICE TECHNICIAN HAS BEEN SENT FOR INVESTIGATION AND FOUND DEFECTIVE CONTROL BOARD TPM. ACCORDING TO SERVICE ORDER THE REPLACEMENT OF THE CONTROL BOARD SOLVED THE ISSUE. THE CONTROL BOARD HAS BEEN RECEIVED FOR FURTHER INVESTIGATION AT MAQUET LABORATORY. ACCORDING TO INVESTIGATION REPORT, SIGNED ON (B)(6)2018 , THE FAILURE COULD NOT BE REPRODUCED. SINCE THE ISSUE HAS BEEN SOLVED, ACCORDING TO THE SERVICE REPORT, BY REPLACING THE CONTROL BOARD IT HAS TO BE ASSUMED THAT THERE IS A SPORADIC ERROR. THUS THE FAILURE COULD BE CONFIRMED. MOST PROBABLE ROOT CAUSE COULD NOT BE DETERMINED AS FAILURE WAS NOT REPRODUCIBLE. 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. SINCE THE REPORTED FAILURE DID NOT CONTRIBUTE TO A DEATH OR SERIOUS INJURY NO CORRECTIVE ACTION IS NEEDED. IN ADDITION AT THIS TIME IT CANNOT BE CONCLUDED THAT THIS IS A SYSTEMIC ERROR. NO CORRECTIVE ACTION IS NEEDED.

    Description of Event or Problem · 0

    INTERNAL REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). FIELD SERVICE TECHNICIAN HAS BEEN SENT FOR INVESTIGATION AND FOUND DEFECTIVE CONTROL BOARD TPM SO. ACCORDING TO SERVICE ORDER REPLACEMENT OF THE CONTROL BOARD SOLVED THE ISSUE. THE CONTROL BOARD WAS RETURNED FOR TO MANUFACTURER FOR FURTHER INVESTIGATION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AFTER NEW INFORMATION HAS BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT, AWARENESS DATE AND INTERNAL REFERENCE # HAVE BEEN CHANGED FROM WHAT WAS SUBMITTED ON THE INITIAL REPORT.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER, SAFETY-S ERROR OCCURRED ON THE TWIN PUMP MODULE. NO KNOWN CONSEQUENCES TO PATIENT. (B)(4).

    Description of Event or Problem · 1

    INTERNAL REFERENCE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517869 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY AG MCP00706195

    Patients

    Seq Age Sex Outcome Treatment
    1