BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2010314 · Received February 11, 2011

    Report

    Report Number
    9616066-2011-00047
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    December 23, 2010
    Report Date
    December 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
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 02/11/2011. (B)(4). PRODUCT EVALUATED AND THE CUSTOMER'S REPORT OF A LEAK FROM THE PUMPING SEGMENT WAS CONFIRMED. A 0.1025 INCH LONG TEAR WAS NOTED ON THE SILICONE TUBING NEAR THE UPPER FITMENT. MULTIPLE CRUSH MARKS WERE DETECTED ON THE UPPER FITMENT. NO OTHER ANOMALIES OF THE ADMINISTRATION SET WERE NOTED. THE CAUSE OF THE LEAK WAS DUE TO A TEAR IN THE PUMPING SEGMENT; HOWEVER, THE ROOT CAUSE OF THE TEAR WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED FLUID LEAKED FROM THE PUMPING SEGMENT. LEVOPHED WAS INFUSING WHEN THE NURSE NOTED THE MEDICATION LEAKING FROM THE BOTTOM OF THE PUMP ONTO THE FLOOR. THE ADMINISTRATION SET WAS REPLACED AND THE INFUSION RESTARTED WITHOUT INCIDENT. NO PT HARM REPORTED AND NO MEDICAL INTERVENTION REQUIRED. NO ADD'L EVENT INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP. 2420-0007 10115031

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK 0.9% SODIUM CHLORIDE 250 ML BAG WITH| ALARIS PC UNIT, SN UNK| ALARIS PUMP MODULE, SN UNK| NOREPINEPHRINE BITARTRATE