BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SECONDARY ADMINISTRATION SET

    MDR report key: 3944165 · Received May 7, 2014

    Report

    Report Number
    9616066-2014-00449
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K931550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE PRODUCT WAS DISCARDED. THE CUSTOMER COMPLAINT OF THE DAPTOMYCIN INFUSION WAS OBSERVED DRIPPING AT APPROXIMATELY THE SAME RATE AS THE PRIMARY LINE COULD NOT BE CONFIRMED DUE TO THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ADMINISTRATION SET WAS SET UP INCORRECTLY ON PATIENT'S IV LINE. THE SECONDARY TUBING AND MEDICATION WERE CONNECTED TO SMARTSITE JUST BELOW THE PUMP. THE DAPTOMYCIN INFUSION WAS OBSERVED DRIPPING AT APPROXIMATELY THE SAME RATE AS THE PRIMARY LINE. IT IS UNKNOWN THE LENGTH OF TIME THE ANTIBIOTIC HAD BEEN INFUSING. THE RN CORRECTED THE SET UP AND CONNECTED THE SECONDARY TO THE PORT ABOVE THE PUMP. THERE WAS NO REPORT OF PATIENT HARM OR MEDICAL INTERVENTION. THE CUSTOMER STATED THAT NO FURTHER PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274991 ALARIS SECONDARY ADMINISTRATION SET FPA CAREFUSION CORPORATION 11448964 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS ADMIN SET: MODEL 2426-0500, LOT UNK| ALARIS PC UNIT: SN UNK| PUMP MODULE: SN UNK