BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 8115627 · Received November 29, 2018

    Report

    Report Number
    9616066-2018-02334
    Event Type
    Malfunction
    Date Received
    November 29, 2018
    Date of Event
    June 25, 2018
    Report Date
    November 9, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    07613203019460
    PMA / PMN Number
    K894842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S REPORT OF BLOOD LEAKAGE NOTED ON THE DISTAL CONNECTION WAS NOT CONFIRMED. VISUAL INSPECTION OF THE AS-RECEIVED SET NOTED DRIED BLOOD RESIDUE AROUND THE EXIT LUER OF THE SET. FUNCTIONAL TESTING WAS PERFORMED; NO OBVIOUS LEAKING WAS OBSERVED WITH THE RECEIVED SET OR COMPONENTS. NO MATING COMPONENT WAS RECEIVED FOR INVESTIGATION. THE ROOT CAUSE OF THE REPORTED BLOOD LEAKAGE NOTED ON THE DISTAL CONNECTION WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED BLOOD LEAKAGE NOTED ON THE DISTAL CONNECTION AFTER ONE HOUR OF THE PRBC INFUSION. THE VOLUME OF O POSITIVE, RH POSITIVE BLOOD WAS 280 VTBI. NO PATIENT HARM WAS REPORTED

    Additional Manufacturer Narrative · 1

    THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BLOOD LEAKAGE NOTED ON THE DISTAL CONNECTION AFTER ONE HOUR OF THE PRBC INFUSION. THE VOLUME OF O POSITIVE, RH POSITIVE BLOOD WAS 280 VTBI. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954146 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2477-0007 18015976 07613203019460

    Patients

    Seq Age Sex Outcome Treatment
    1 8015,8100,O POSITIVE BLOOD BAG, TD (B)(6) 2018| 8015,8100,O POSITIVE BLOOD BAG, TD (B)(6) 2018