BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 7767943 · Received August 9, 2018

    Report

    Report Number
    1828100-2018-00416
    Event Type
    Malfunction
    Date Received
    August 9, 2018
    Date of Event
    July 18, 2018
    Report Date
    August 9, 2018
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTQ
    PMA / PMN Number
    K172220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PST OBSERVED THE INTEGRATED CIRCUIT (IC) U16 TO BE BLOWN AND A HOLE IN THE PLASTIC PACKAGE NEAR PINS SIX AND SEVEN ON THE POWER MANAGER BOARD, WHICH IS CONSISTENT WITH OF A CATASTROPHIC POWER EVENT SUCH AS AN INADVERTENT SHORT CIRCUIT. THERE WAS ALSO CHARRING OF THE PLASTIC CASE OF IC U13 OBSERVED NEAR PINS ONE AND TWO ON THE NETWORK INTERFACE CARD (NIC), WHICH ARE GROUND AND +5 PINS RESPECTIVELY. THE POWER MANAGER BOARD AND BOTH NETWORK NIC BOARDS ATTACHED TO THE +5 VDC AND GND ON ALL THREE BOARDS WERE AFFECTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    THE PRODUCT SURVEILLANCE TECHNICIAN (PST) REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE FIVE VOLTS DIRECT CURRENT (VDC) TO GROUND (GND) HAD A SHORT CIRCUIT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608546 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 801763

    Patients

    Seq Age Sex Outcome Treatment
    1