BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 16689952 · Received April 6, 2023

    Report

    Report Number
    2016493-2023-140926
    Event Type
    Malfunction
    Date Received
    April 6, 2023
    Date of Event
    March 13, 2023
    Report Date
    April 17, 2023
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 0

    CORRECTION : DISREGARD THE MFR REPORT # 2016493-2023-140926. AFTER FURTHER REVIEW, IT WAS DETERMINED THE REPORT IS A DUPLICATE OF THE PREVIOUSLY REPORTED EVENT CAPTURED UNDER MFR REPORT # 2016493-2023-132499.

    Description of Event or Problem · 0

    A COPY OF THE MEDWATCH REPORT FROM FDA WAS RECEIVED, WHICH STATES, ¿PATIENT RECEIVING IV MEDICATION VIA CAREFUSION INFUSION PUMP. AFTER 35 MINS THE ENTIRE INFUSION COMPLETED. ON REVIEW IT WAS IDENTIFIED THE INFUSION PUMP MALFUNCTIONED DUE TO A BROKEN MODULE PLATEN HINGE SPRING ASSEMBLY. NO IDENTIFIED PATIENT HARM." IT WAS REPORTED AN OVER INFUSION EVENT AND IT WAS LATER FOUND THAT THE TOP HINGE OF THE PLATEN WAS BROKEN. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Description of Event or Problem · 0

    A COPY OF THE MEDWATCH REPORT FROM FDA WAS RECEIVED, WHICH STATES, ¿PATIENT RECEIVING IV MEDICATION VIA CAREFUSION INFUSION PUMP. AFTER 35 MINS THE ENTIRE INFUSION COMPLETED. ON REVIEW IT WAS IDENTIFIED THE INFUSION PUMP MALFUNCTIONED DUE TO A BROKEN MODULE PLATEN HINGE SPRING ASSEMBLY. NO IDENTIFIED PATIENT HARM.". IT WAS REPORTED AN OVER INFUSION EVENT AND IT WAS LATER FOUND THAT THE TOP HINGE OF THE PLATEN WAS BROKEN. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911864 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 8015