BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2123512 · Received June 8, 2011

    Report

    Report Number
    9616066-2011-00303
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATED AND CUSTOMER'S REPORT OF LEAK WAS CONFIRMED. LEAKING WAS OBSERVED AT THE ENGAGEMENT BETWEEN THE NITRO TUBING AND UPPER FITMENT ENGAGEMENT. THE ROOT CAUSE OF THE LEAK IS DUE TO INSUFFICIENT SOLVENT APPLIED AT THE ENGAGEMENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT LIPOSOMAL DOXORUBICIN (250ML VOLUME) WAS INFUSING AT 83.3 ML/HR AND WAS WITHIN 30 MINUTES OF COMPLETION WHEN A DROP OF RED CHEMO FLUID WAS OBSERVED ON THE TOP PORTION OF THE SET'S UPPER FITMENT, AT THE JUNCTION OF THE TUBING. INFUSION WAS CONTINUED UNTIL COMPLETED. THERE WAS NO PATIENT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 10015048 10125401

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ALARIS PC UNIT: S/N (B)(4)| ALARIS PUMP MODULE: S/N (B)(4)| PORTA CATHETER| 250ML BAXTER BAG: LOT C819276, EXP. MAY 2012| 100ML B. BRAUN BAG: LOT J0N902, EXP. JULY 2011