BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HL-20 INTEGRATED PERFUSION SYSTEM

    MDR report key: 7079103 · Received December 4, 2017

    Report

    Report Number
    8010762-2017-00376
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Date of Event
    December 17, 2017
    Report Date
    August 27, 2018
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K943803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED THE DATE OF EVENT WHICH WAS NOTED INCORRECTLY ON THE INITIAL MEDWATCH AS (B)(6) 2017 TO (B)(6) 2017. MAQUET MEDICAL SYSTEMS,USA(IMPORTER)SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31, 76437 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).

    Additional Manufacturer Narrative · 0

    MAQUET MEDICAL SYSTEMS,USA(IMPORTER)SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31, 76437 RASTATT, GERMANY. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. (B)(4). THE PUMP WAS REQUESTED FOR FURTHER INVESTIGATION. ACCORDING TO THE INVESTIGATION REPORT, THE LEFT PUMP WAS TESTED AND DISPLAYED THE ERROR "RUN-AWAY" AFTER POWER UP. A DEFECT IN THE SPEEDOMETER OF THE LEFT ENGINE WAS DETERMINED AS ROOT CAUSE FOR THE ERROR MESSAGE AND THE UNEVEN TURNING OF THE PUMP HEAD AT LOW SPEED. THUS THE FAILURE COULD BE CONFIRMED. THE PUMP WAS SENT TO THE REPAIR CENTER FOR REPLACEMENT OF THE MOTOR. ACCORDING TO SERVICE ORDER #(B)(4) THE TECHNICIAN REPLACED THE TPM MOTOR ON (B)(6) 2018. IN ADDITION THE OPTICAL TACHO BOARD AND THE INTERCONNECTION BOARD WAS REPLACED. SYSTEM TEST WAS PERFORMED ACCORDING TO THE SERVICE PROTOCOL - ALL TESTS PASSED. 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) / ONESUPPORT (B)(4).

    Description of Event or Problem · 0

    INTERNAL REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. (B)(4). THE PUMP WAS REQUESTED FOR FURTHER INVESTIGATION. ACCORDING TO THE INVESTIGATION REPORT, THE LEFT PUMP WAS TESTED AND DISPLAYED THE ERROR "RUN-AWAY" AFTER POWER UP. A DEFECT IN THE SPEEDOMETER OF THE LEFT ENGINE WAS DETERMINED AS ROOT CAUSE FOR THE ERROR MESSAGE AND THE UNEVEN TURNING OF THE PUMP HEAD AT LOW SPEED. THUS THE FAILURE COULD BE CONFIRMED. THE PUMP WAS SENT TO THE REPAIR CENTER FOR REPLACEMENT OF THE MOTOR. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP WAS REQUESTED FOR FURTHER INVESTIGATION. HOWEVER THE PUMP WAS NOT SENT TO LCE RASTATT DESPITE SEVERAL REQUESTS. THE COMPLAINT WILL BE RE-OPENED IF REQUESTED PART OR ANY NEW RELEVANT INFORMATION IS RECEIVED. THUS THE 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. 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 · 1

    IT WAS STATED THAT THE LEFT PUMP OF TPM SHOWS THE ERROR "RUNAWAY" IF RUNNING AT SPEEDS LESS THAN 36 RPM. FAILURE OCCURRED DURING STARTUP. NO PATIENT INVOLVED. INTERNAL REFERENCE: (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    INTERNAL REFERENCE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861011 HL-20 INTEGRATED PERFUSION SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY AG MCP00706195

    Patients

    Seq Age Sex Outcome Treatment
    1