BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2251661 · Received August 10, 2011

    Report

    Report Number
    9616066-2011-00453
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Report Date
    July 27, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER COMPLAINT OF SECONDARY MEDICATION BACKING UP INTO PRIMARY COULD NOT BE CONFIRMED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. THE SETS WERE DISCARDED BY THE CUSTOMER. THE ROOT CAUSE OF THE FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED NURSE PROGRAMMED PUMP WITH A SECONDARY MEDICATION OF AMIODARONE (RATE UNK). FLUID WAS BACKING UP INTO PRIMARY, HEAD HEIGHT DIFFERENTIAL REPOSITIONED WITHOUT SUCCESS. AFTER SEVERAL ATTEMPTS, SECONDARY DRIP DISCONTINUED AND MEDICATION ADMINISTERED AS A PRIMARY. SETS HAVE BEEN DISCARDED. NO PT HARM OR MEDICAL INTERVENTION REPORTED. PRIMARY SET AS AN ALARIS SECONDARY SET WAS BAXTER PLUS A PALL FILTER. DEVICES WERE SENT TO BIOMED TO CHECK. IF ADDITIONAL TESTING IS REQUESTED BY CUSTOMER, BIOMED WILL SEND IN THE DEVICE TO CAREFUSION AND PROVIDE SERIAL NUMBERS. ALTHOUGH REQUESTED, NO FURTHER PT OR EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP. 2426-0500 UNK

    Patients

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