BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PC UNIT

    MDR report key: 10610479 · Received September 30, 2020

    Report

    Report Number
    2016493-2020-16192
    Event Type
    Malfunction
    Date Received
    September 30, 2020
    Date of Event
    September 2, 2020
    Report Date
    September 2, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K091308
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER COMPLAINT REPORTED THAT THERE WERE DEFECTIVE PCU (8015) KEYPADS RESULTING IN THE DEVICES NOT TURNING ON WAS CONFIRMED AND REPLICATED DURING FUNCTIONAL TESTING. THE CUSTOMER REPORTED THAT THESE DEVICES WERE OUT OF BOX FAILURES, HOWEVER SIGNS OF FLUID INGRESS INDICATE THAT SOME USAGE OCCURRED. INSPECTION: EXTERNAL AND INTERNAL INSPECTION WAS PERFORMED ON (QTY 10 P/N TC10013664). DURING EXTERNAL INSPECTION, 12 OUT OF THE 12 RETURNED KEYPADS WERE OBSERVED TO BE IN GOOD CONDITION WITH NO OBVIOUS ISSUES OBSERVED. DURING INTERNAL INSPECTION, 9 OUT OF 10 KEYPADS WERE FOUND WITH SIGNS OF FLUID INGRESS NEAR WHERE THE FLEX CABLE MEETS THE CIRCUIT LAYER AND THE REMAINING KEYPAD WAS OBSERVED IN GOOD CONDITION WITH NO OBVIOUS ISSUES OBSERVED. LOG ANALYSIS RESULTS: N/A ¿ NO LOGS WERE PROVIDED. TEST RESULTS: THE FRONT CASE KEYPADS (QTY 10 P/N TC10013664) WERE CONNECTED TO A CAD PCU TEST FIXTURE #10013973 (EQ 111582) FOR FUNCTIONAL TESTING. THREE (3) OUT OF THE 10 RETURNED KEYPADS PASSED THE MAINTENANCE KEYPAD TEST DUE TO ALL SOFT KEYS FUNCTIONING AS INTENDED. ONE (1) OUT OF THE 10 RETURNED KEYPADS FAILED THE MAINTENANCE KEYPAD TEST DUE TO FAILING TO POWER ON THE DEVICE. SIX (6) OUT OF THE 10 RETURNED KEYPADS FAILED THE MAINTENANCE KEYPAD TEST DUE TO POWERING ON THE DEVICE IMMEDIATELY AFTER BEING PLUGGED TO THE FIXTURE WHICH RESULTS IN THE SYSTEM ON KEY FAILING TO POWER ON THE DEVICE AFTER BEING TURNED OFF. 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 REVIEW OF THE PCU MODULE 15890591 SERVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 05/14/2020. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS PERFORMED BEGINNING FROM THE DATE OF MANUFACTURE TO THE PRESENT DATE 11/05/2020 AND INDICATED THAT THIS DEVICE HAS NOT BEEN RETURNED TO SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE DEFECTIVE PCU (8015) KEYPADS RESULTING IN THE DEVICES NOT TURNING ON. IT WAS NOTED THAT THE THIS WAS AN OUT OF BOX FAILURE. THERE WAS NO PATIENT HARM. THE ISSUES WERE NOTED BEFORE PATIENT USE.

    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 THERE WERE DEFECTIVE PCU (8015) KEYPADS RESULTING IN THE DEVICES NOT TURNING ON. IT WAS NOTED THAT THE THIS WAS AN OUT OF BOX FAILURE. THERE WAS NO PATIENT HARM. THE ISSUES WERE NOTED BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074496 ALARIS PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1