BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1873435 · Received October 14, 2010

    Report

    Report Number
    9616066-2010-00300
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    July 29, 2010
    Report Date
    August 26, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATED AND CUSTOMER'S REPORT OF A LEAK WAS CONFIRMED, HOWEVER, LEAKING WAS OBSERVED ON THE SILICONE SEGMENT AND NOT THE SMARTSITE PORT AS REPORTED. THE LEAK WAS CAUSED BY A PINHOLE APPROX 0.0415 INCHES LONG IN THE SILICONE TUBING NEAR THE UPPER FITMENT. CRUSH MARKS WERE ALSO OBSERVED ON THE UPPER FITMENT. THE ROOT CAUSE OF THE PINHOLE WAS NOT IDENTIFIED. LOT NUMBER WAS NOT REPORTED. BASED ON THE SMARTSITE LASER NUMBER, THE MFG DATABASE WAS REVIEWED AND NO QUALITY ISSUES WERE NOTED DURING PRODUCTION BUILD OF THIS MODEL FOR THE FAILURE MODE REPORTED.

    Description of Event or Problem · 1

    IN THE OICU, IT WAS REPORTED THAT THE PUMP BEEPED FOR AIR-IN-LINE MULTIPLE TIMES AND THEN IT WAS NOTED THAT THERE WAS LEAKING FROM ONE OF THE SMARTSITE PORTS. THE PT LOST SOME OF THE IL-2 (CHEMO REGIMEN) THAT WAS INFUSING AND THERE WAS A DELAY IN GETTING MORE OF THE MEDICATION. NO PT HARM. 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 2420-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ADD-ON BURETTE, MODEL 82113E, LOT NUMBER UNK| ALARIS PUMP MODULE, SERIAL NUMBER UNK