BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3170897 · Received June 5, 2013

    Report

    Report Number
    9616066-2013-00408
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Report Date
    May 8, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED LEAK BECAUSE THE SET HAD BEEN DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LEAKING FROM THE SILICONE SEGMENT CAUSING FLUID TO LEAK INTO THE PUMP. THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO FURTHER PT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249385 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE: SN UNKNOWN| ALARIS PC UNIT: SN UNKNOWN