BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2082574 · Received April 27, 2011

    Report

    Report Number
    9616066-2011-00167
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: APRIL 27, 2011. (B)(4). THE CUSTOMER REPORTS THAT THE SET HAS BEEN DISCARDED; THEREFORE, A FAILURE INVESTIGATION COULD NOT BE PERFORMED. UNABLE TO DETERMINE THE CAUSE OF THE REPORTED LEAK.

    Description of Event or Problem · 1

    CUSTOMER REPORTED BUSULFAN INFUSION LEAK FROM "PUMP SEGMENT" OF CHEMO TUBING. REMOVED TUBING FROM PUMP AND CLAMPED PICC AND CHEMO TUBING TO PREVENT FURTHER LEAKING. INFUSION RESTARTED WITH NEW CHEMO TUBING. SET WAS NOT SAVED. THERE WAS NO REPORTED HARM TO PT OR USER AND NO MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2120-0500 11015841

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR ALARIS PC UNIT, S/N UNKNOWN| ALARIS PUMP MODULE, S/N UNKNOWN