BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PC UNIT

    MDR report key: 2190073 · Received June 29, 2011

    Report

    Report Number
    2016493-2011-00392
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    May 11, 2011
    Report Date
    June 8, 2011
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K051641
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BUT THE EVAL HAS NOT YET BEGUN. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    REPORT RECEIVED THAT THE CUSTOMER IS HAVING DISCREPANCIES WITH CHEMOTHERAPY INFUSIONS WHERE THE INFUSIONS ARE TAKING TOO LONG TO INFUSE. A 23 HOUR INFUSION OF CHEMOTHERAPY (5-FLUOROURACIL) WAS SCHEDULED TO COMPLETE AT 00:30AM ON (B)(6) 2011, BUT COMPLETED AT 4:00AM ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PC UNIT FRN CAREFUSION CORP 8000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK A PHASEAL CLOSED SYSTEM DEVICE, MODEL & LOT # UNK| ALARIS PUMP MODULE, S/N (B)(4)| ALARIS ADMINISTRATION SET| SODIUM CHLORIDE, 1000 ML BAG OF 0.9%, LOT UNK| ALARIS PUMP MODULE, S/N (B)(4)| MICROCLAVE, MODEL & LOT # UNK