BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 6182805 · Received December 16, 2016

    Report

    Report Number
    9616066-2016-01848
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    December 5, 2016
    Report Date
    December 5, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: TEVADAPTOR BAG ACCESS ADAPTER; 500 ML BAG CONTAINING APPROXIMATELY 400 ML OF ETOPOSIDE 200 MG IN 0.9% SODIUM CHLORIDE INJECTION, USP (B. BRAUN 500 ML, NDC 0264-7800-10, REF L8001, LOT NUMBER J6C293, EXP: 09/2018); TEVADAPTOR SYRINGE ADAPTOR; THERAPY DATE (B)(6) 2016. THE CUSTOMER¿S REPORT OF A LEAK WAS CONFIRMED. VISUAL INSPECTION OF THE SUSPECT PRIMARY SET UNDERNEATH MAGNIFICATION OBSERVED THAT THERE WAS A TINY PIN-HOLE ON THE TOP OF THE PISTON OF THE DISTAL SMARTSITE VALVE. FUNCTIONAL TESTING CONFIRMED A LEAK AT THE LOCATION OF THE PIN-HOLE ON THE DISTAL SMARTSITE VALVE OF THE SUSPECT PRIMARY SET. THE ROOT CAUSE OF THE LEAK WAS A TINY PIN HOLE ON THE TOP OF THE PISTON OF THE DISTAL SMARTSITE VALVE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN INFUSION OF ETOPOSIDE 200MG IN 0.9% NACL 500ML LEAKED ONTO THE PATIENT'S BLANKET WHILE CONNECTED TO HER. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FLUID ¿SPRAYED¿ FROM THE END OF THE INFUSION SET ONTO THE PATIENT¿S BLANKET AND POSSIBLY PANT LEG AND LEG DURING AN INFUSION OF ETOPOSIDE 200 MG IN 500 ML OF 0.9% NACL. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833955 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2426-0007

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR