BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM PC UNIT

    MDR report key: 10633079 · Received October 6, 2020

    Report

    Report Number
    2016493-2020-17924
    Event Type
    Malfunction
    Date Received
    October 6, 2020
    Report Date
    September 11, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K091308
    Removal / Correction Number
    Z-2909-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED COMPLAINT OF THE KEYPADS BEING REPLACED DUE TO FAILED KEYS WAS EVALUATED. SEVEN KEYPADS WERE CONFIRMED TO HAVE A FAULTY SYSTEM ON KEYS AND NONFUNCTIONING AC INDICATOR LIGHTS. INSPECTION: IT WAS REPORTED THAT THE FRONT CASES WITH KEYPADS ARE BEING REPLACED DUE TO FAILED KEYS. THE FRONT CASE KEYPADS WERE RETURNED INSIDE A CARBOARD BOX. THE SERIAL NUMBERS FOR THE KEYPADS WERE WRITTEN ON THE FRONT DISPLAY SCREENS SUSPECTED TO BE FROM THE PCUS FROM WHICH THEY WERE REMOVED. ALL PARTS INSPECTED ARE MANUFACTURED BY BD. EXTERNAL AND INTERNAL INSPECTION WAS PERFORMED ON (QTY 7 PRINTEC P/N TC10013664 AND QTY 2 PRINTEC P/N TC10012515). DURING INTERNAL INSPECTION, THE KEYPADS WERE FOUND WITH SIGNS OF FLUID INGRESS WHERE THE FLEX CABLE MEETS THE CIRCUIT LAYER AND BROKEN TRACES (TRACE 19 AND 20). DURING EXTERNAL INSPECTION, THE KEYPADS WERE IN GOOD CONDITION WITH NO ISSUES OBSERVED. PN, DATE CODE, S/N, LOT # , AND MAINTENANCE KEYPAD TEST RESULTS. TC10010217, 18/02, (B)(6), 060308, AC INDICATOR LIGHT DID NOT FUNCTION. SYSTEM ON KEY DID NOT FUNCTION. ALL OTHER KEYS ON THE KEYPAD WERE FUNCTIONING AS INTENDED. TEST RESULTS IDENTIFIED THAT THE AC INDICATOR LIGHTS DID NOT ILLUMINATE AFTER PLUGGING IN THE POWER CORD ON 4 OUT 9 KEYPADS. ALL OTHER KEYS ON THESE KEYPADS WERE FUNCTIONING AS INTENDED. THE PROXIMATE CAUSE OF THE CUSTOMER¿S EXPERIENCE WITH KEYPAD FAILURES IS SUSPECTED TO BE ASSOCIATED TO KEYPAD TRACE DAMAGE RESULTING FROM FLUID INGRESS ENTERING THE KEYPAD CIRCUIT LAYER. DEVICE HISTORY REVIEW: REVIEW OF THE PCU MODULE S/N (B)(6) SERVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 19-APR-2018. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS PERFORMED BEGINNING FROM THE DATE OF MANUFACTURE TO THE PRESENT DATE 09-NOV-2020 AND INDICATED THAT THIS DEVICE HAS NOT BEEN RETURNED TO SERVICE. REVIEW OF THE PRODUCTION FAILURE RECORD WAS PERFORMED BEGINNING FROM THE DATE OF MANUFACTURE THROUGH PRESENT. THE FAILURE RECORD SHOWED NO PRODUCTION FAILURE RECORDS WERE OPENED FOR THE SOURCE DEVICE. H3 OTHER TEXT : ONLY THE FRONT CASE W/ KEYPAD ASSEMBLY WAS RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 9 FRONT CASES OF THE PC UNIT ARE BEING REPLACED DUE TO FAILED KEYS. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    NO DEVICE WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 9 FRONT CASES OF THE PC UNIT ARE BEING REPLACED DUE TO FAILED KEYS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101340 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1