BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1913446 · Received November 24, 2010

    Report

    Report Number
    9616066-2010-00342
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 17, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LEAK WAS CONFIRMED WITH A TEAR NOTED IN THE SILICONE SEGMENT NEAR THE UPPER FITMENT, MEASURING 0.1155 INCHES. CRUSH MARKS WERE NOTED ON THE UPPER FITMENT. ROOT CAUSE OF THE TEAR WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE USER WAS TROUBLESHOOTING AN AIR IN LINE ALARM ON THE PUMP, AND TOOK THE SET OUT OF THE PUMP SEVERAL TIMES TO FLICK VISIBLE AIR BUBBLES OUT OF THE SILICONE SEGMENT IN A BUBBLY ETOPOSIDE INFUSION. ON THE THIRD ATTEMPT, SHE FLICKED IT WITH HER PEN, AND AFTER CLOSING THE PUMP DOOR, THE MED STARTED SPURTING OUT OF THE SET JUST BELOW THE UPPER FITMENT. THERE WAS NO PT OR STAFF EXPOSURE OR HARM. NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 11607704 10085245

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE, SERIAL NUMBER UNKNOWN