BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1833447 · Received September 8, 2010

    Report

    Report Number
    9616066-2010-00252
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    June 24, 2010
    Report Date
    June 25, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATED AND CUSTOMER'S EXPERIENCE OF TUBING SEPARATED AT THE LOWER FITMENT WAS CONFIRMED. A VISUAL INSPECTION OF THE SET NOTED THAT THE SILICONE TUBING WAS SEPARATED AT THE LOWER FITMENT. THE RING RETAINER, WHICH SECURES THE TUBING IN PLACE, WAS PRESENT ON THE TUBING. THE CAUSE OF THE SEPARATION WAS NOT IDENTIFIED. THE LOT NUMBER WAS NOT IDENTIFIED. BASED ON THE SMARTSITE LASER NUMBER, THE MANUFACTURING DATABASE WAS REVIEWED; NO QUALITY ISSUES WERE NOTED DURING PRODUCTION BUILD PERIOD (SET WAS BUILT BETWEEN 27 APRIL 2010 AND 01 JUNE 2010) OF THIS MODEL FOR THE FAILURE MODE REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED WHEN PUMP BEEPED FOR AIR-IN-LINE, THE NURSE TOOK THE IV TUBING OUT OF THE PUMP TO REMOVE THE AIR BUBBLES AND WHILE DOING THAT THE TUBING SEPARATED FROM THE BLUE CLAMP. THERE WAS NO PATIENT HARM. 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 2420-0500 UNK

    Patients

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