BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 6498779 · Received April 17, 2017

    Report

    Report Number
    9616066-2017-00620
    Event Type
    Malfunction
    Date Received
    April 17, 2017
    Date of Event
    March 22, 2017
    Report Date
    March 29, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: NON-CFN/BD EXTENSION SET; 2000ML BAXTER EXACTAMIX BAG REF (B)(4) LOT 1201166 EXP (B)(6) 2019; CUROS INJECTION CAP; THERAPY DATE (B)(6) 2017. 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

    AFTER REVIEW IT WAS DETERMINED THAT THIS COMPLAINT IS NOT MDR REPORTABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY ARE HAVING AIR IN LINE ISSUES WITH TPN INFUSIONS. DURING AN INFUSION OF TPN @ 40ML/HR, VOLUME OF 1060ML, WITH A FILTER, AIR BUBBLES ARE SEEN AT THE INJECTION PORT ABOVE THE PUMP. THE BUBBLES CONNECT TO FORM A LARGER BUBBLE THAT IS LARGE ENOUGH TO MAKE THE PUMP ALARM WITH "AIR IN LINE", A CUROS INJECTION CAP WAS PLACED ON THE PORT AND THIS STOPPED THE AIR BUBBLE COLLECTION. THE DATA SET SHOWS THAT THERE WERE 10 "BOLUS AIR-IN-LINE" ALARMS. THE NEXT DAY AFTER A NEW TPN BAG WAS HUNG THERE WERE AN ADDITIONAL EIGHT "BOLUS-AIR-IN-LINE" ALARMS. THERE IS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279905 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2426-0500

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR 8100, 8015, THERAPY DATE