BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 6744688 · Received July 26, 2017

    Report

    Report Number
    9616066-2017-01061
    Event Type
    Malfunction
    Date Received
    July 26, 2017
    Date of Event
    July 2, 2017
    Report Date
    July 7, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: NON-BD SET; 500ML B.BRAUN BAG NDC 0264-7800-10, LOT NUMBER J7E219, EXP (B)(6) 2019 ETOPOSIDE. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF A LEAK FROM AN UNSPECIFIED LOCATION WAS CONFIRMED. FUNCTIONAL TESTING CONFIRMED A LEAK FROM A CRACK ON THE UPPER FITMENT. CLOSER INSPECTION FOUND STRESS MARKS AT THE CRACK SITE. THE CRACK MEASURED 0.148 INCHES LONG AND IS LOCATED 0.38 INCHES ABOVE THE BOTTOM OF THE UPPER FITMENT. THE ROOT CAUSE OF THE LEAK IS A CRACK IN THE UPPER FITMENT. THE ROOT CAUSE OF THE CRACK COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TUBING LEAKED AT AN UNSPECIFIED LOCATION DURING AN ETOPOSIDE CHEMOTHERAPY ADMINISTRATION. THERE WAS NO REPORT OF PATIENT HARM.

    Description of Event or Problem · 1

    THE INFUSION WAS ETOPOSIDE (TOPOSAR) 83MG IN 0.9% NACL 500ML INFUSING AT A RATE OF 20.8ML/HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525577 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 10013361

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR SPIRO CONNECTOR, THERAPY DATE (B)(6) 2017