BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 11045837 · Received December 21, 2020

    Report

    Report Number
    2016493-2020-73094
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Report Date
    July 30, 2019
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORTED PROBLEM WAS CONFIRMED. 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. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT

    Description of Event or Problem · 1

    CASE #: 00784717 NPI ERROR CODE 800-8000 ON 8015LS UNIT BATTERY PACK- LOW CAPACITY SOFTWARE FAILURE- 800 8000 OS FAILURE THERE WAS NO PATIENT INVOLVEMENT. BD QUALITY ADVOCATE, THIS NOTIFICATION IS TO INFORM YOU THAT A NEW CASE HAS BEEN CREATED WITH THE COMPLAINT TYPE CATEGORY INFUSION CA. CASE #: 00784717 CASE SUBJECT: NPI ERROR CODE 800-8000 ON 8015LS UNIT ACCOUNT NAME: PRISMA HEALTH TUOMEY ACCOUNT #: 1813400 ASSET NAME: 8015LS PCU DOM V9.19.1.2 A/B/G ASSET LOCATION: CONTACT: BRADY PRIVETTE CONTACT EMAIL: CONTACT PHONE: CONTACT MOBILE: PATIENT OR USER INVOLVEMENT: NO PATIENT OR USER HARM: NO CASE DESCRIPTION: TECH. CALLED IN FOR HELP ON 8015LS UNIT SERIAL # (B)(4) HAS ERROR CODE 800-8000 FAILURE DEVICE TYPE: ALARIS SYSTEM INSTRUMENT FAILURE PROBLEM TYPE: 8015 FAILURE MODE: TROUBLESHOOTING/ ERROR CODES CASE RESOLUTION: CONFIRM ERROR CODE 800.8000 IS A SOFTWARE FAULT WILL NEED TO REFLASH SOFTWARE ON UNIT IF FLASHING UNIT FAILS NEXT STEP IS REPLACE THE LOGIC BOARD ON THE UNIT. TECH. THANK ME FOR MY ASSIST (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1517133 8015 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1