BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2190078 · Received June 29, 2011

    Report

    Report Number
    9616066-2011-00347
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    May 30, 2011
    Report Date
    June 1, 2011
    Manufacturer
    CAREFUSTION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BUT IT HAS NOT BEEN EVALUATED. A F/U REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A SET WAS LEAKING AND CRACKED. CUSTOMER REPORTED WHEN CHANGING TPN/LIPIDS TUBING WAS FOUND TO BE IN TWO PIECES. CUSTOMER STATES NO FURTHER PT OR EVENT INFO IS AVAILABLE. NO PT HARM OR INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSTION CORP 2420-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK