BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 11655441 · Received April 13, 2021

    Report

    Report Number
    11655441
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    March 16, 2021
    Report Date
    April 1, 2021
    Manufacturer
    CHF SOLUTIONS INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS EVENT IS RELATED TO MEDSUN REPORT (B)(4). LIGHT PINK TINGED IN THE EFFLUENT. IN MORNING, NOTED LIGHT PINK COLOR IN THE EFFLUENT. PU=300 DURING THIS TIME. TESTED EFFLUENT SAMPLE WITH BLOOD LEAK STRIP AND IT TURNED POSITIVE. SENT EFFLUENT SAMPLE TO LAB FOR FURTHER TESTING. TAGGED AQUADEX MACHINE AND CARTRIDGE. REPLACED AQUADEX MACHINE AND USED A DIFFERENT LOT NUMBER OF AQUADEX CARTRIDGE. RESTARTED AQUAPHERESIS WITH NORMAL EFFLUENT AMBER COLOR. PU=124 AT START TIME. REPLACED MACHINE AQUADEX MACHINE AND AQUADEX CARTRIDGE. THE AQUADEX SMARTFLOW DID NOT ALARM BLOOD LEAK. WE WERE NOT SURE IF IT WAS A TRUE BLOOD LEAK OR NOT BUT PINK EFFLUENT WAS VISIBLE IN THE DRAIN BAG. CHF SOLUTION SALES REP. WAS NOTIFIED OF THE ISSUE AND IT WAS SWAP WITH A DIFFERENT DEVICE, WITH THE MACHINE TAG. THE CARTRIDGE SET LOT # THAT WAS USED FOR THIS PATIENT WAS 20871. CHF SOLUTION BELIEVE THEIR IS NO RECALL ON THIS LOT # BUT TO BE SAFE, STAFF WAS INFORM NOT TO USE AND THE CARTRIDGE WAS REPLACED IMMEDIATELY BY CHF SOLUTION. CHF SOLUTION CAME ON SITE TO TEST THE EFFECTED SMARTFLOW DEVICE FOR BLOOD LEAK DETECT AND THERE WAS NO ISSUE FOUND WITH THE DEVICE. THE TEST PASSED WITH BLOOD LEAK ALARM. RECEIVED OKAY TO USE FROM CHF SOLUTION TO PLACE SMARFLOW BACK IN SERVICE. BIOMED AND TEAM NOTIFIED AND AWARE. CHF SOLUTION WILL PROVIDE A DOCUMENTATION OF OKAY TO USE. THERE WAS NO DETECTABLE HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555005 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI CHF SOLUTIONS INC. AQUADEX SMART FLOW 120100 20871

    Patients

    Seq Age Sex Outcome Treatment
    1 30 DA