BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SECONDARY SET

    MDR report key: 6100091 · Received November 14, 2016

    Report

    Report Number
    9616066-2016-01562
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 26, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K053049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 24301-0007T; B.BRAUN 1000ML BAG OF 0.9% NACL INJECTION, NDC 0264-7800-09, EXP DATE 03/18, LOT # J5L763; B.BRAUN 250ML DOCETAXEL (TAXOTERE), NDC 0264-7800-20, EXP DATE 06/18, LOT # J6H262; B.BRAUN 250ML RAMUCIRUMAB, NDC 0264-7800-20, EXP DATE 06/18, LOT # J6H262, THERAPY DATE (B)(6) 2016. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF ¿LEAK¿ WAS NOT CONFIRMED. THE SETS WERE VISUALLY INSPECTED FOR KINKS, HOLES/TEARS IN THE TUBING OR DAMAGES TO THE COMPONENTS. NO ANOMALIES WERE OBSERVED ON THE SET. FUNCTIONAL AND PRESSURE TESTING RESULTED IN NO SIGNS OF LEAKING OR OCCLUSION ANYWHERE ON THE RETURNED SET WHILE THE TUBING WAS MANIPULATED AT EACH ENGAGEMENT. THE ROOT CAUSE OF THE CUSTOMER¿S REPORT OF A ¿LEAK¿ WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT WAS RECEIVING TAXOTERE CHEMOTHERAPY. WHILE ADDRESSING THE END OF INFUSION ALARM AND SWITCHING TO THE PRIMARY SALINE INFUSION, THE NURSE NOTED LIQUID ON HIS/HER THUMB AND A FEW DROPS ON THE BOTTOM OF THE IV POLE, DETERMINED TO BE LEAKING FROM THE BONDED, CLOSED SYSTEM VALVE ATTACHED TO THE CHEMO SECONDARY TUBING. IT WAS DETERMINED THAT LESS THAN 5ML HAD LEAKED. THE NURSE FLUSHED AND WASHED HANDS FOR 6-8 MINUTES, AND NO HARM TO THE NURSE OR PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750975 ALARIS SECONDARY SET SET, SECONDARY, INTRAVASCULAR FPA CAREFUSION 10013364T

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR 11171447,8100,8000,10012241-0500