BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PC UNIT

    MDR report key: 10578058 · Received September 23, 2020

    Report

    Report Number
    2016493-2020-10045
    Event Type
    Malfunction
    Date Received
    September 23, 2020
    Date of Event
    August 21, 2020
    Report Date
    August 26, 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
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT THE SILENCE, S6, 1, AND CLEAR KEYS ARE UNRESPONSIVE WAS CONFIRMED. EXTERNAL AND INTERNAL INSPECTION WAS PERFORMED ON (P/N TC10012515). DURING EXTERNAL INSPECTION, THE KEYPADS WERE OBSERVED TO BE IN GOOD CONDITION WITH NO IRREGULARITIES OBSERVED. DURING INTERNAL INSPECTION THE KEYPAD WAS FOUND WITH SIGNS OF FLUID INGRESS WHERE THE FLEX CABLE MEETS THE CIRCUIT LAYER. CRACKS UNDER MAGNIFICATION WERE ALSO FOUND ON THE TRACES OF THE CIRCUIT LAYER FOR (P/N TC10012515). THE FRONT CASE KEYPAD (P/N TC10012515) WAS CONNECTED TO THE CAD PCU TEST FIXTURE #: (B)(4) (EQ 111582) FOR FUNCTIONAL TESTING. THE AC INDICATOR LIGHT ILLUMINATED AS EXPECTED AND VARIOUS KEYS (S6, SILENCE, 1, 4, 7, CLEAR) ON THE KEYPAD WERE FOUND TO BE NOT 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. REVIEW OF THE SN (B)(6) SERVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 02/12/2019. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS PERFORMED BEGINNING FROM THE DATE OF MANUFACTURE TO THE PRESENT DATE 10/26/2020 AND INDICATED THAT THIS DEVICE HAS BEEN RETURNED FOR SERVICE OF THIS ISSUE UNDER COMPLAINT FILE (B)(4). 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 KEY PADS RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE KEYPAD WILL BE REPLACED. BIOMED STATED : "SILENCE, S6, 1, AND CLEAR ARE UNRESPONSIVE". THE CUSTOMER STATED THAT THERE WAS NO PATIEN INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD WILL BE REPLACED. BIOMED STATED : "SILENCE, S6, 1, AND CLEAR ARE UNRESPONSIVE". THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042262 ALARIS PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1