BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2140559 · Received June 15, 2011

    Report

    Report Number
    9616066-2011-00316
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Report Date
    May 4, 2011
    Manufacturer
    CAREFUSION 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT WAS EVALUATED AND THE SET WAS DETERMINED TO HAVE A LEAK DUE TO A TEAR IN THE SILICONE TUBING AT THE UPPER FITMENT. ROOT CAUSE OF TEAR IN THE SILICONE TUBING WAS UNDETERMINED. ALTHOUGH LOT NUMBER UNK, THE SMARTSITE LASER NUMBER INDICATES THIS SET WAS BUILT BETWEEN (B)(4) 2010.

    Description of Event or Problem · 1

    CUSTOMER RETURNED THIS ADMINISTRATION SET IN THE SAME PACKAGE WITH SETS EXPECTED FOR OTHER FILES. THE SET APPEARS TO BE USED BUT UNK IF THE SET WAS FROM A PT OR ONLY FROM PRIMING. NO INDICATION OF THE REASON FOR THE RETURN. UNABLE TO REACH MULTIPLE HOSPITAL CONTACTS. NO FURTHER PT OR EVENT INFO IS AVAILABLE.

    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