BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1873436 · Received October 14, 2010

    Report

    Report Number
    9616066-2010-00296
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    June 25, 2010
    Report Date
    June 29, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S EXPERIENCE OF DISCONNECTED TUBING WAS CONFIRMED. THE SILICONE TUBING OF THE PUMPING SEGMENT WAS OBSERVED TO BE SEPARATED FROM THE UPPER FITMENT. THE O-RING WAS NOT PRESENT, HOWEVER, VISUAL INSPECTION USING THE OPTICAL MICROSCOPE REVEALED A WEAK MARK INDICATING THAT THE O-RING WAS PRESENT AT SOME TIME. THE ROOT CAUSE OF THE SEPARATION WAS NOT IDENTIFIED. THE LOT NUMBER WAS NOT IDENTIFIED. BASED UPON THE SMARTSITE LASER NUMBER, THE POSSIBLE LOT NUMBERS WERE REVIEWED AND NO QUALITY ISSUES WERE NOTED DURING PRODUCTION BUILD FOR THE FAILURE MODE REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A TUBING SET DISCONNECTED INSIDE THE PUMP DURING CHEMOTHERAPY ADMINISTRATION. A SPILL OF DOCETAXEL OCCURRED AS A RESULT. THE TUBING CAME APART WHERE THE SOFT TUBING GOES OVER THE MALE BLUE CONNECTOR AT THE TOP. NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 10013072 UNK

    Patients

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