BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 11053209 · Received December 22, 2020

    Report

    Report Number
    2016493-2020-76079
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Report Date
    December 10, 2019
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORTED COMPLAINT OF BLINKING PCU AC INDICATOR LIGHTS WAS CONFIRMED ON TWO OF THE SIX RETURNED SWITCHING POWER SUPPLIES DURING THE INVESTIGATION. TESTING CONFIRMED THE FAILURE ON TWO OF THE RETURNED SWITCHING POWER SUPPLIES DURING TESTING. TEST RESULTS DEMONSTRATED THAT POWER SUPPLIES S/N K0737F64 AND S/N K0737M16 FAILED TO PRODUCE 24VDC WHEN CONNECTED TO AN AC POWER SOURCE. BASED ON PREVIOUS FAILURE INVESTIGATION FI 2013-0019, IT IS SUSPECTED THAT THE FAILED SWITCHING POWER SUPPLIES MAY HAVE BEEN EXPERIENCING A MALFUNCTION WITH POTENTIOMETER R13 PREVIOUSLY KNOWN TO PRODUCE THIS TYPE OF FAILURE. THERE WAS NO PATIENT INVOLVEMENT RELATED TO THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED FROM THE DATE OF THE MANUFACTURE TO DATE OF THE RELEASE OF PRODUCT, WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE, AND PRODUCT WAS NOT RETURNED FOR SERVICING WHICH NOT CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD IN THE TRACKWISE WAS PERFORMED FOR THE SN (B)(4) WHICH CONFIRMED NO SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. CAPA REFERENCE: (B)(4). THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PCU AC LED INDICATOR BLINKING; ONGOING POWER SUPPLY ASSEMBLY ISSUES. BIOMED STATED:".IN ORDER TO RESOLVE THE PROBLEM AFTER PERFORMING SERIES OF TROUBLESHOOTING STEPS I ALWAYS END UP REPLACING THE POWER SUPPLY ASSEMBLY (H0000082).WHEN PLUGGED IN AND TURNED ON, SEEING A FLASHING AC INDICATOR MEANS THAT THE POWER SUPPLY BOARD IS CONSTANTLY SWITCHING BACK AND FORTH BETWEEN AC AND BATTERY POWER AS THE SWITCHING POWER SUPPLY IS NOT PUTTING OUT A GOOD 24VDC TO THE POWER SUPPLY BOARD." THE CUSTOMER STATED; "NO PATIENT RELATED INCIDENT CAME TO OUR ATTENTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520114 8015 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015

    Patients

    Seq Age Sex Outcome Treatment
    1