BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SECONDARY SET

    MDR report key: 5894250 · Received August 22, 2016

    Report

    Report Number
    9616066-2016-01126
    Event Type
    Malfunction
    Date Received
    August 22, 2016
    Report Date
    August 10, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K053049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    HOSPIRA 250ML BAG NDC 0409-7922-02, LOT 57-019-JT, 5% DEXTROSE INJECTION; HOSPIRA 100ML BAG NDC 0409-7923-37, LOT 63-119-JT, EXP 1 MAR 2018, 5% DEXTROSE INJECTION, THERAPY DATE UNK. THE CUSTOMER¿S REPORT OF A LEAK AT THE TEXIUM/SMARTSITE CONNECTION POINT WAS NOT CONFIRMED. THE SETS AND COMPONENTS WERE VISUALLY INSPECTED FOR OBVIOUS DAMAGE SUCH AS INCOMPLETE BONDING ENGAGEMENTS, CRACKS, KINKS, HOLES, AND TEARS. NO ANOMALIES OR EVIDENCE OF DAMAGE WAS OBSERVED. THE ACTUATOR TABS OF THE TEXIUM ADAPTORS WERE NOT DAMAGED. FUNCTIONAL AND PRESSURE TESTING WAS PERFORMED; NO LEAKING WAS OBSERVED. DUE TO THE DUAL THREAD FEATURE OF BOTH THE SMARTSITE AND TEXIUM LUERS MAKING TWO DIFFERENT CONNECTION/THREADING CONFIGURATIONS POSSIBLE, THE SETS WERE DISCONNECTED AND REATTACHED SUCH THAT THE SECOND THREADING CONFIGURATION WAS EMPLOYED. NO LEAKS WERE OBSERVED. EACH SET WAS THEN TESTED INDIVIDUALLY AND NO LEAKS WERE OBSERVED. THE ROOT CAUSE WAS NOT IDENTIFIED BECAUSE NO FAULT WAS FOUND WITH THE RETURNED SETS.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK WHERE THE TEXIUM CONNECTED TO A SMARTSITE DURING AN INFUSION OF DOXIL CHEMOTHERAPY. THERE WAS NO REPORT OF ANY PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546415 ALARIS SECONDARY SET SET, SECONDARY, INTRAVASCULAR FPA CAREFUSION 10013364T

    Patients

    Seq Age Sex Outcome Treatment
    1