BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 6357006 · Received February 24, 2017

    Report

    Report Number
    2016493-2017-00177
    Event Type
    Malfunction
    Date Received
    February 24, 2017
    Date of Event
    February 3, 2017
    Report Date
    February 4, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION ON INITIAL REPORT: THE SUSPECT DEVICE IS NOW A DISPOSABLE PRODUCT AND REQUIRES A NEW MANUFACTURER REPORT NUMBER. PLEASE REFERENCE MANUFACTURER REPORT NUMBER 9616066-2017-00792 FOR MDR REPORTING.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT(S): NON-CFN SECONDARY SET; NON-CFN BAG ACCESS; 500ML B. BRAUN BAG NDC 0264-7800-10, LOT J6P163, EXP 5/2019, ETOPOSIDE (VEPESID) IN 0.9% NACL; 250ML B.BRAUN BAG, NDC 0264-7800-20, LOT J5N172, EXP 10/2017, 0.9% NACL INJECTION; BBRAUN SECONDARY TUBING, THERAPY DATE (B)(6) 2017. NO DEVICE WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE DEVICE WAS NOT SEQUESTERED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED. THE AFFECTED CONCOMITANT PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE ETOPOSIDE INFUSION WAS SUPPOSED TO BE COMPLETED, THERE WAS FLUID REMAINING IN THE BAG. THE PUMP NEVER SWITCHED FROM SECONDARY TO PRIMARY AND THE PUMP WAS ALARMING FOR "AIR IN LINE". INSIDE THE CHAMBER WERE LARGE AIR BUBBLES. THERE IS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140135 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR 8015,MP1000-C,2429-0500, TD (B)(6) 2017