BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11061165 · Received December 22, 2020

    Report

    Report Number
    2016493-2020-77467
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Report Date
    December 12, 2019
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    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 DHR (DEVICE HISTORY RECORD) REVIEW CANNOT BE COMPLETED AS THE SERIAL NUMBER WAS NOT OBTAINED UPON RECEIPT OF THE COMPLAINT. ADDITIONALLY, A HISTORICAL REVIEW OF COMPLAINTS IN TRACKWISE CANNOT BE CONDUCTED. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    CASE #: 00929259 CASE SUBJECT: NPI 8100 DOOR OPEN ALARMS ACCOUNT NAME: NEBRASKA ORTHOPAEDIC HOSPITAL ACCOUNT #: 10011610 ASSET NAME: 8100 PUMP MODULE, V8 ASSET LOCATION: CONTACT: JOSIAH ABERNATHEY CONTACT EMAIL: [email protected] CONTACT PHONE: 402-609-1106 CONTACT MOBILE: PATIENT OR USER INVOLVEMENT: NO PATIENT OR USER HARM: NO CASE DESCRIPTION: JOSIAH HAD A "DOOR OPEN" ALARMS ON LVP8100 SN (B)(4) FAILURE DEVICE TYPE: ALARIS SYSTEM INSTRUMENT FAILURE PROBLEM TYPE: 8100 FAILURE MODE: TROUBLESHOOTING/ ERROR CODES CASE RESOLUTION: I RECOMMENDED JOSIAH TO REPLACE AIL SENSOR. JOSIAH WILL REPLACE AIL SENSOR. IF HE STILL HAVE PROBLEM, HE WILL CALL ME BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1523606 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1