BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 11138535 · Received January 8, 2021

    Report

    Report Number
    2016493-2021-03566
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Report Date
    February 4, 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 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 #: 00983112 CASE SUBJECT: NPI 8015 ERROR 133.6080 ACCOUNT NAME: OHIO STATE UNIVERSITY HOSPITALS ACCOUNT #: 19995789 ASSET NAME: ASSET LOCATION: CONTACT: BRYCE PALM CONTACT EMAIL: [email protected] CONTACT PHONE: 717-575-1533 CONTACT MOBILE: PATIENT OR USER INVOLVEMENT: NO PATIENT OR USER HARM: NO CASE DESCRIPTION: CALLER HAS AN 8015 UNIT GIVING HIM A 133.6080 ERROR. SN: (B)(4) FAILURE DEVICE TYPE: FAILURE PROBLEM TYPE: FAILURE MODE: CASE RESOLUTION: USED KA 11952 ALARIS INFUSION ERROR 133.6080 TO TROUBLESHOOT. CAUSE WAS DUE TO A LOW BATTERY CHARGE. HAD BIOMED CHARGE THE BATTERY AND ISSUE RESOLVED. REF:_00D30Y0YR._5000L1QKFWV:REF

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39458 8015 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1