BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SYSTEM

    MDR report key: 15500851 · Received September 28, 2022

    Report

    Report Number
    2016493-2022-198955
    Event Type
    Injury
    Date Received
    September 28, 2022
    Date of Event
    May 13, 2022
    Report Date
    October 13, 2022
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    ADDITIONAL INFORMATION : IMDRF ANNEX A AND G CODES.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED FROM HEALTH (B)(6) VIGILANCE PROGRAM WHICH STATES, "POTENTIAL OVER INFUSION OR FAILED BACK CHECK VALVE BOTH PRIMARY AND SECONDARY BAGS RAPIDLY INFUSING -BOTH BAGS EMPTIED BIOMED REPORT COMPLETED - #(B)(4) RAPID PANTAMIDINE INFUSION - PATIENT C/O SHARP CENTRALIZED ABDO PAIN VS STABLE BENADRYL GIVEN PATIENT LEFT WALKING 2 1/2 HOURS LATER ALARIS PUMP C550361 CHANNEL C549711 NOT SURE IF TUBING ISSUE OR PUMP ISSUE PUMP AND TUBING SEQUESTERED FOR BIOMED TO ASSESS."

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED FROM HEALTH CANADA'S CANADA VIGILANCE PROGRAM WHICH STATES, "POTENTIAL OVER INFUSION OR FAILED BACK CHECK VALVE BOTH PRIMARY AND SECONDARY BAGS RAPIDLY INFUSING -BOTH BAGS EMPTIED BIOMED REPORT COMPLETED - #436798 RAPID PANTAMIDINE INFUSION - PATIENT C/O SHARP CENTRALIZED ABDO PAIN VS STABLE BENADRYL GIVEN PATIENT LEFT WALKING 2 1/2 HOURS LATER ALARIS PUMP C550361 CHANNEL C549711 NOT SURE IF TUBING ISSUE OR PUMP ISSUE PUMP AND TUBING SEQUESTERED FOR BIOMED TO ASSESS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2363494 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention 8015