BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 6283142 · Received January 27, 2017

    Report

    Report Number
    9616066-2017-00097
    Event Type
    Malfunction
    Date Received
    January 27, 2017
    Date of Event
    November 28, 2016
    Report Date
    January 4, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: NON-CFN SECONDARY SET; TWO PHASEAL ADAPTERS; 250ML BAXTER BAG NDC (B)(4), LOT Y213165, EXP APR 18, GEMCITABINE , SODIUM CHLORIDE 0.9%; 250ML BAXTER BAG NDC (B)(4), LOT Y213629, EXP APR 18, 0.9% SODIUM CHLORIDE INJECTION; 7 EMPTY BAGS LOT NUMBERS16093042 X3 ,16097772 X4; THERAPY DATE (B)(6) 2016. 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 THE DISTAL SMARTSITE PORT WAS CONFIRMED. A PUNCTURE WITH A TEAR WAS OBSERVED ON THE SURFACE OF THE DISTAL SMARTSITE¿S BLUE PISTON TO ONE SIDE OF THE PISTON SLIT. FUNCTIONAL TESTING WAS PERFORMED; LIQUID WAS OBSERVED FLOWING THROUGH THE TUBING AND EXITING THROUGH THE DISTAL MALE LUER. LIQUID WAS ALSO OBSERVED TO LEAK FROM THE BLUE PISTON OF THE DISTAL SMARTSITE PORT, CONFIRMING THE CUSTOMER¿S REPORT. THE SET WAS THEN PRESSURE TESTED; A LEAK (BUBBLES) WAS OBSERVED ORIGINATING FROM THE DISTAL SMARTSITE PISTON. THE CAUSE OF THE LEAK WAS DUE TO A DAMAGED/PUNCTURED SMARTSITE PISTON. THE ROOT CAUSE OF THE PISTON DAMAGE/PUNCTURE IS A MANUFACTURING ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED IV PEPCID WAS PUSHED THROUGH THE PORT CLOSEST TO THE PATIENT AND FOLLOWING THE IV PUSH GEMCITABINE 2 GM(1520MG IN 250 ML) WAS INITIATED AS A SECONDARY INFUSION TO INFUSE OVER 30 MINUTES. NEAR THE END OF THE INFUSION IT WAS NOTICED THAT THE CHEMO WAS LEAKING OUT OF THE PORT THAT THE PEPCID WAS PUSHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65472 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2426-0500

    Patients

    Seq Age Sex Outcome Treatment
    1