BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1935414 · Received December 15, 2010

    Report

    Report Number
    9616066-2010-00364
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    September 18, 2010
    Report Date
    September 29, 2010
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 12/15/2010. (B)(4). THIS REPORT WAS FILED BY THE MFR. PRODUCT EVALUATED AND CUSTOMER'S REPORT OF LEAK FROM A TEAR IN THE SILICONE SEGMENT WAS CONFIRMED. THE TUBING SEPARATED FROM THE UPPER BLUE FITMENT, THE RETAINING RING WAS PRESENT AND THE SILICONE TUBING APPEARED TORN. A CRUSH MARK WAS NOTED ON THE UPPER FITMENT. THE ROOT CAUSE OF THE SEPARATION WAS NOT IDENTIFIED. THE LOT NUMBER WAS NOT IDENTIFIED. BASED UPON SMARTSITE VALVE LASER NUMBER, SET WAS MFG BETWEEN 06/29/2010 AND 07/01/2010. EXP DATE IS EITHER 06/01/2013 OR 07/01/2013.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE IV TUBING SEVERED BELOW THE UPPER FITMENT, RESULTING IN A LEAK. DOPAMINE WAS INFUSING AT THE TIME, THE PT'S BLOOD PRESSURE REMAINED STABLE WHILE THE USER REPLACED THE TUBING AND RESTARTED THE INFUSION. NO PT HARM REPORTED. NO ADDITIONAL 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 69 YR ALARIS PUMP MODULE, SERIAL NUMBER UNK| ALARIS PC UNIT, SERIAL NUMBER UNK