BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1933994 · Received December 1, 2010

    Report

    Report Number
    9616066-2010-00357
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 18, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATED AND CUSTOMER'S REPORT OF LEAKING IN THE PUMPING SEGMENT WAS CONFIRMED. A TEAR APPROXIMATELY 0.0350 INCHES LONG WAS FOUND IN THE SILICONE TUBING NEAR THE UPPER FITMENT. A CRUSH MARK WAS NOTED ON THE UPPER FITMENT. THE LOT NUMBER WAS NOT IDENTIFIED. BASED ON THE SMARTSITE LASER NUMBER, THE SET WAS BUILT BETWEEN 07/02/2010 AND 07/07/2010. THE ROOT CAUSE OF THE TEAR WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ICU FOUND IV TUBING CRACKED AT THE PUMPING SEGMENT. ENTIRE BAG OF INSULIN LEAKED ON FLOOR. NO PATIENT HARM REPORTED; USER FOUND LEAK RIGHT AWAY. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2426-0500 UNKNOWN

    Patients

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