BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION

    MDR report key: 2904464 · Received December 5, 2012

    Report

    Report Number
    9616066-2012-00880
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Report Date
    October 3, 2012
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S REPORT OF THE SET LEAKED WAS CONFIRMED. ALTHOUGH THERE WERE NO SIGNS OF THE SET BEING POPPED OUT OF ANY LOCATION OF THE COMPONENTS PER CUSTOMER'S NOTE. DURING VISUAL INSPECTION OF THE SET IT WAS NOTED THAT THE SILICONE SEGMENT HAD A TEAR NEAR THE UPPER FITMENT. VISUAL EXAMINATION UNDER THE MICROSCOPE DID NOT NOTE ANY CRUSH MARKS TO THE UPPER FITMENT. FUNCTIONAL TESTING WAS PERFORMED AND A LEAK WAS NOTED COMING FROM THE SILICONE TUBING NEAR THE UPPER FITMENT. THE CAUSE OF THE LEAK WAS DUE TO A TEAR IN THE SILICONE SEGMENT. HOWEVER THE ROOT CAUSE OF THE TEAR WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A LEAK IN THE TUBING THAT CONTAINED AN INVESTIGATION ((B)(4)) MEDICATION. THE PHARMACY TECH WAS ADJUSTING THE TUBING WHEN IT POPPED AND LEAKED. NO REPORT OF PT OR STAFF HARM. 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 FPA CAREFUSION CORPORATION 10015048 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK