BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 11139823 · Received January 8, 2021

    Report

    Report Number
    2016493-2021-03956
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Report Date
    February 3, 2020
    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 TRACKWISE COMPLAINT HISTORY REVIEW WAS COMPLETED, AND IT WAS CONFIRMED THAT THERE WERE ADDITIONAL COMPLAINTS RECEIVED WITH SIMILAR SN (B)(4) FOR THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    BD QUALITY ADVOCATE, THIS NOTIFICATION IS TO INFORM YOU THAT A NEW CASE HAS BEEN CREATED WITH THE COMPLAINT TYPE CATEGORY INFUSION CA. CASE #: 00981681 CASE SUBJECT: NPI 8015LS UNIT WILL NOT POWER ON ACCOUNT NAME: UNIVERSITY MARYLAND MEDICAL CENTER ACCOUNT #: 10057884 ASSET NAME: 8015LS PCU DOM V9.33.1.2 A/B/G/N ASSET LOCATION: CONTACT: GUY ROGER TAKAM CONTACT EMAIL: [email protected] CONTACT PHONE: 4103288088 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) FAILURE DEVICE TYPE: FAILURE PROBLEM TYPE: FAILURE MODE: CASE RESOLUTION: TECH CALLED FOR HELP ON 8015LS UNIT WITH ERROR SAYING POWER DEVICE NOT IN USE, BUT UNIT WAS POWER OFF WHEN CALLED IN, SO TRY TO GET TECH TO POWER ON UNIT AND HE WAS UNABLE TO, TECH SAID LET ME CALL BACK ONCE HE GET UNIT POWER ON REF:_00D30Y0YR._5000L1QKYTQ:REF

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35633 8015 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1