BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 19545126 · Received June 17, 2024

    Report

    Report Number
    2016493-2024-29518
    Event Type
    Malfunction
    Date Received
    June 17, 2024
    Date of Event
    April 1, 2024
    Report Date
    August 27, 2024
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810046
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION : DESCRIBE EVENT OR PROBLEM, UNIQUE DEVICE IDENTIFIER (UDI)#, PMA / 510(K)#. ADDED PI TO THE UNIQUE DEVICE IDENTIFIER (UDI)# FIELD. ADDITIONAL INFORMATION : IMDRF ANNEX B CODE AND MANUFACTURER NARRATIVE. A DEVICE HISTORY RECORD REVIEW IS PERFORMED ON EACH DEVICE REPORTED IN A MDR REPORTABLE EVENT ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT.

    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.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED FROM HEALTH CANADA'S CANADA VIGILANCE PROGRAM WHICH STATES, "NO OUTCOME ON THE PATIENT AS IT WAS CAUGHT JUST IN TIME. HOWEVER, THIS WAS A NEAR MISS - GAVE POTENTIAL FOR AN AIR EMBOLUS IN PICC LINE." THERE WAS PATIENT INVOLVEMENT BUT NO HARM. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED FROM HEALTH CANADA'S CANADA VIGILANCE PROGRAM WHICH STATES, "NO OUTCOME ON THE PATIENT AS IT WAS CAUGHT JUST IN TIME. HOWEVER, THIS WAS A NEAR MISS - GAVE POTENTIAL FOR AN AIR EMBOLUS IN PICC LINE." THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009596 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8015