BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 11664022 · Received April 14, 2021

    Report

    Report Number
    2016493-2021-502523
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Report Date
    March 19, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION ADDED TO: ANNEX G.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE EXPERIENCED A CHANNEL ERROR AND TURNED OFF. THE CUSTOMER BELIEVES THE CAUSE TO BE A CORRODED IUI OR SOFTWARE ISSUE. THERE WAS NO REPORTED ADVERSE EFFECTS CAUSED TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION. ALTHOUGH REQUESTED, THE AFFECTED DEVICE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXPERIENCED A CHANNEL ERROR AND TURNED OFF. THE CUSTOMER BELIEVES THE CAUSE TO BE A CORRODED IUI OR SOFTWARE ISSUE. THERE WAS NO REPORTED ADVERSE EFFECTS CAUSED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564691 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 8015.| PRI TUBING.| 8015| PRI TUBING