BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOSI-FUSER

    MDR report key: 5690716 · Received May 25, 2016

    Report

    Report Number
    MW5062546
    Event Type
    Malfunction
    Date Received
    May 25, 2016
    Date of Event
    May 2, 2016
    Report Date
    May 25, 2016
    Manufacturer
    LEVENTON SAU
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DOSI-FUSER (GRIFOLS) IS AN ELASTOMERIC INFUSER THAT WAS IMPLEMENTED AS A REPLACEMENT FOR THE CADD PRISZM PUMPS. CURRENTLY, WE HAVE APPROXIMATELY 5-10 PATIENTS PER WEEK THAT IS USING DOSI-FUSER. THE TYPICAL REGIMEN CALLS FOR THE MEDICATION TO BE GIVEN OVER 46 HOURS. THERE IS A STANDARD DEVIATION OF PLUS/MINUS 10 PERCENT VARIABILITY FOR INFUSION TIME. OVER A TWO-WEEK PERIOD FROM (B)(6) 2016 6 OUT OF 14 PATIENTS EXPERIENCED EARLY COMPLETION OF THEIR INFUSIONS WITH THE DOSI-FUSER, WITH COMPLETION TIMES RANGING FROM 5 HOURS TO 9.5 HOURS AHEAD OF SCHEDULE. WITH A PLANNED INFUSION TIME OF 46 HOURS, A STANDARD DEVIATION OF PLUS/MINUS 10 PERCENT WOULD ALLOW NORMAL VARIATION WITHIN 4.6 HOURS. EARLY COMPLETION TIMES OF 5-9.5 HOURS AHEAD OF PLAN EXCEED THE STANDARD DEVIATION. INTERNAL INVESTIGATION CONFIRMED THAT THE MEDICATIONS FOR INFUSION WERE PREPARED AND PACKAGED CORRECTLY AND THAT THE DOSI-FUSERS WERE PREPARED CORRECTLY. INTERNAL INVESTIGATION ALSO CONFIRMED THAT NURSING STAFF APPLIED THE DOSI-FUSERS TO THE PATIENTS CORRECTLY AND WITH THE APPROPRIATE TECHNIQUE. NONE OF THE 6 PATIENTS EXPERIENCED ANY HARM, ALTHOUGH THE POTENTIAL FOR HARM EXISTS AND HAS BEEN DEEMED SIGNIFICANT ENOUGH TO REMOVE THE DOSI-FUSERS FROM SERVICE IN FAVOR OF ALTERNATIVE MEANS OF HOME INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335068 DOSI-FUSER INFUSION PUMP FRN LEVENTON SAU 250D2 150959L

    Patients

    Seq Age Sex Outcome Treatment
    1