BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIVATORS

    MDR report key: 5069235 · Received September 10, 2015

    Report

    Report Number
    2184009-2015-00078
    Event Type
    Malfunction
    Date Received
    September 10, 2015
    Date of Event
    July 1, 2015
    Report Date
    August 13, 2015
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    KDI
    PMA / PMN Number
    K983085
    Removal / Correction Number
    2184009-8-20-2015-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE PRODUCT WAS NOT RETURNED, THE COMPLAINT WAS CONFIRMED. THERE HAS BEEN AN ISSUE NOTED RELATED TO THE HPH700 NOT MEETING THE REQUIREMENT FOR ULTRA-FILTRATION EFFICIENCY. MEDTRONIC INITIATED A FORMAL INVESTIGATION INTO THE PERFORMANCE ISSUES AND WORKED WITH MEDIVATORS TO TEST AND IDENTIFY ALL POTENTIALLY AFFECTED UNITS. A FIELD ACTION WAS INITIATED TO ADDRESS ALL PRODUCTS IN THE FIELD. THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED. MEDTRONIC WILL CONTINUE TO MONITOR FOR FUTURE EVENTS. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE PERFUSIONIST OBSERVED THAT THE MEDIVATORS HEMOCONCENTRATOR WITHIN THEIR MEDTRONIC PERFUSION PACK WAS NOT ACHIEVING THE FILTRATION RATE THEY EXPECTED. DIFFERENT PUMPING METHODS AND APPLICATION OF NEGATIVE PRESSURE WERE ATTEMPTED TO IMPROVE THE FILTRATION RATE, BUT WERE UNSUCCESSFUL. THE HEMOCONCENTRATOR WAS REPLACED WITH A HPH-1000 STANDALONE HEMOCONCENTRATOR TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS ISSUE. THE PRODUCT WAS DISCARDED AT THE CUSTOMER SITE AND WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600195 MEDIVATORS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI MEDTRONIC PERFUSION SYSTEMS HPH-700 759491A

    Patients

    Seq Age Sex Outcome Treatment
    1