BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2121140 · Received May 4, 2011

    Report

    Report Number
    9616066-2011-00178
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    February 15, 2011
    Report Date
    April 7, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: (B)(4) 2011. (B)(4). THE DEVICE HAS BEEN RECEIVED, HOWEVER, THE INVESTIGATION HAS NOT YET BEEN COMPLETED. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION HAS BEEN DONE.

    Description of Event or Problem · 1

    CUSTOMER REQUESTED EVALUATION OF IV SET. VAGUE EVENT REPORT RECEIVED. STATED THE IV PIGGY BACK MEDICATION WAS HUNG HIGHER THAN THE PRIMARY, THEN THE PUMP ALARMED FOR AIR-IN-LINE. THE SECONDARY WAS EMPTY AND THE PRIMARY BAG HAD MORE FLUID THAN WHEN IT STARTED. NO HARM TO THIS 15 YEAR OLD FEMALE PATIENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR ALARIS PC UNIT: S/N UNKNOWN| ALARIS PUMP MODULE: S/N UNKNOWN