BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3902583 · Received May 9, 2014

    Report

    Report Number
    1828100-2014-00399
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 14, 2001
    Report Date
    April 17, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS RELATED TO THE FOLLOWING MDRS: 1828100-2014-00398, 1828100-2014-00401 AND 1828100-2014-00402. THE CUSTOMER IS ORDERING REPLACEMENT BATTERIES. ADDITIONAL INFORMATION FROM THE CUSTOMER: I WANTED TO DESCRIBE THE PROBLEM WHICH CAME TO ME AFTER THE INSTALLATION OF THE SYSTEM-1, ALL DEVICES SHIPPED WITH NON-WORKING BATTERIES, WHICH DO NOT HOLD A CHARGE EVEN FOR A MINUTE. AFTER CHECKING THEIR MULTIMETER, EACH BATTERY SHOWED 4.5 VOLTS BUT NEED 12 VOLTS, THIS WAS THE FIRST PROBLEM. THE SECOND ISSUE, I TOOK GOOD BATTERIES FROM OTHER SYSTEM-1 DEVICE AND TEMPORARILY INSTALLED ON THE SYSTEM-1 TO CHECK THE BATTERY CHARGE AND GENERAL SETTINGS. THERE WERE NO ISSUES, THE DEVICE OPERATED AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER INSTALLATION OF THE PERFUSION SYSTEM AND DURING THE FIRST START-UP, THE BATTERY LIGHT EMITTING DIODE (LED) WAS YELLOW. THIS IS CONSIDERED AN "OUT OF BOX" FAILURE. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION FROM THE CUSTOMER: DURING THE FIRST START-UP, THE FIRST LIGHT UP THE LED WAS YELLOW. WHEN CHECKING THE CENTRAL CONTROL MONITOR (CCM) UNDER THE SERVICE MENU, THE DEVICE SHOWED BATTERY CAPACITY WAS LESS THAN FIFTEEN AMPS. I LEFT THE DEVICE CHARGING FOR THIRTEEN HOURS AND CHECKED THE SERVICE MENU REGARDING CHARGE STATUS. THERE WAS A MARKED "1" MEANING THE CHARGE WAS ON. AFTER THE SPECIFIED TIME, THE LED DID NOT TURN GREEN COLOR AND THE AMPS DID NOT CLIMB MORE THAN SIXTEEN. I DECIDED TO CHECK THE DEVICE AND UNPLUGGED IT FROM THE WALL AND AFTER THREE SECONDS, THE DEVICE TURNED OFF COMPLETELY. AFTER I TURNED THE DEVICE ON AGAIN, THE LED WAS RED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282282 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (HEART LUNG CONSOLE) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801764

    Patients

    Seq Age Sex Outcome Treatment
    1