BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 7119437 · Received December 14, 2017

    Report

    Report Number
    9616066-2017-01627
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Date of Event
    November 6, 2017
    Report Date
    November 29, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF A TEXIUM LEAK AT THE CONNECTION TO THE SMARTSITE WAS NOT CONFIRMED. VISUAL INSPECTION (INCLUDING MICROSCOPIC) DID NOT SHOW ANY ANOMALIES OR DAMAGE TO THE SET. FUNCTIONAL AND PRESSURE TESTING WAS PERFORMED; NO LEAKS WERE OBSERVED ON ANY PART OF THE SET. THE SECONDARY SET THAT WAS REPORTED TO BE THE MATING COMPONENT WAS NOT RETURNED FOR INVESTIGATION. THE ROOT CAUSE WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 500ML BAXTER BAG NDC 0338-0017-03, LOT NUMBER Y241000, EXP (B)(6), OXALIPLATIN IN 5% DEXTROSE. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AT THE END OF INFUSING OXALIPLATIN 74MG IN DEXTROSE 5% 500ML, THERE WAS LEAKING FROM WHERE THE TEXIUM ON THE SECONDARY SET CONNECTS TO THE SMARTSITE OF THE PRIMARY TUBING. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895608 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 24601-B007T

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR