BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 11145799 · Received January 11, 2021

    Report

    Report Number
    2016493-2021-05398
    Event Type
    Malfunction
    Date Received
    January 11, 2021
    Report Date
    February 19, 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 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

    BD QUALITY ADVOCATE, THIS NOTIFICATION IS TO INFORM YOU THAT A NEW CASE HAS BEEN CREATED WITH THE COMPLAINT TYPE CATEGORY INFUSION CA. CASE #: 00996081 CASE SUBJECT: NPI ERROR CODE 133.6080 ACCOUNT NAME: BON SECOURS ST MARYS HOSPITAL ACCOUNT #: 1771601 ASSET NAME: 8015LS PCU DOM V9.33.1.2 A/B/G/N ASSET LOCATION: CONTACT: CAMAR LEE CONTACT EMAIL: CONTACT PHONE: (757) 407 4139 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 IN FOR HELP ON 8015LS UNIT HAS ERROR COD E133.6080 WHICH IS THE BACKUP SPEAKER ON UNIT NEEDS TO BE REPLACE, CONFIRM PART NUMBER FOR BACKUP SPEAKER TO TECH. THANK ME FOR MY ASSIST, REF:_00D30Y0YR._5000L1QLJJH:REF

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46148 8015 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1