BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 6722291 · Received July 18, 2017

    Report

    Report Number
    1828100-2017-00310
    Event Type
    Malfunction
    Date Received
    July 18, 2017
    Date of Event
    June 12, 2017
    Report Date
    January 12, 2018
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS NOT VERIFIABLE. NO PRODUCT WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. DILIGENCE FOR PART RETURN AND ADDITIONAL INFORMATION WAS UNSUCCESSFUL. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). PER MANUFACTURER'S SUBSIDIARY, THE UNIT SWITCHES OFF IMMEDIATELY WHEN UNPLUGGED. THE BATTERY COLOR WHEN THE EVENT OCCURRED AND THE POWER LIGHT EMITTING DIODE (LED) ON THE FRONT PANEL WAS GREEN. THIS WAS NOT A BACK UP UNIT AND WAS ACTIVELY USED BY THE FACILITY. THERE WAS NO WARNING TONE HEARD BEFORE THE SYSTEM SHUT DOWN. THE CUSTOMER FULLY DISCHARGES AND CHARGES THE BATTERY AT LEAST ONCE EVERY MONTH. THEY MAINTAIN CHARGE IN BATTERIES BY RUNNING IT ON WALL POWER DURING SURGERIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE (CPB), THE ADVANCED PERFUSION SYSTEM 1 (APS 1) WAS NOT SWITCHING OVER TO BATTERY WHEN THERE WAS LOSS OF POWER. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501357 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 801764

    Patients

    Seq Age Sex Outcome Treatment
    1