BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTBANK SOFTDONOR VERSION 4.5.5

    MDR report key: 20843555 · Received December 3, 2024

    Report

    Report Number
    MW5163102
    Event Type
    Other
    Date Received
    December 3, 2024
    Report Date
    November 22, 2024
    Manufacturer
    SCC SOFT COMPUTER
    Product Code
    MMH
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    I AM WRITING THIS TO REPORT PROBLEMS WITH THE NEW SOFTBANK AND SOFTDONOR SYSTEMS AT CAPE FEAR VALLEY HEALTH SYSTEM. THERE WAS NO TRAINING FOR STAFF BEFORE THE SYSTEM STARTED, AND THIS MAKES IT HARD FOR US TO DO OUR WORK SAFELY. I AM SENDING THIS COMPLAINT WITHOUT GIVING MY NAME BECAUSE I AM AFRAID OF RETALIATION. PROBLEMS WE ARE FACING NO TRAINING FOR STAFF: MANY STAFF, INCLUDING ME, TOLD MANAGEMENT AND LEADERSHIP THAT WE DID NOT GET ANY TRAINING FOR THE NEW SYSTEM. NOBODY HELPED US, AND NOW WE DO NOT KNOW HOW TO USE SOFTBANK OR SOFTDONOR PROPERLY. THIS CAN MAKE THINGS DANGEROUS FOR PATIENTS. MANAGER LIED ABOUT TRAINING: OUR MANAGER, (B)(6), SAID SHE DID TRAINING WITH US, BUT THIS IS NOT TRUE. SHE DID NOT COME TO THE SCHEDULED TRAINING SESSIONS. SAFETY CONCERNS: THE SYSTEM WENT LIVE IN ALL LOCATIONS, INCLUDING THE BLOOD DONOR CENTER, BUT NOBODY KNOWS HOW TO USE IT. THIS IS A BIG RISK FOR PATIENTS. OTHER LOCATIONS CANNOT GET HELP: OTHER PLACES ARE CALLING THE MAIN TRANSFUSION SERVICES DEPARTMENT FOR HELP, BUT WE CANNOT HELP THEM BECAUSE WE ALSO DO NOT UNDERSTAND THE SYSTEM. THIS HAPPENED BEFORE: THIS IS NOT THE FIRST TIME THIS HAPPENED. WHEN THE WELLSKY SYSTEM WAS STARTED, THE SAME PROBLEMS HAPPENED, BUT (B)(6) WAS NOT HELD RESPONSIBLE AND IS STILL THE MANAGER. REQUEST FOR INVESTIGATION PLEASE INVESTIGATE THESE PROBLEMS: WHY THERE WAS NO TRAINING FOR STAFF BEFORE USING SOFTBANK AND SOFTDONOR. WHY THE MANAGER LIED ABOUT TRAINING THE STAFF AND IF ANY TRAINING DOCUMENTATION IS PROVIDED, IT IS FAKE. BECAUSE WE WERE NOT TRAINED. WHY THE SYSTEM WENT LIVE WITHOUT PREPARING STAFF. WHY THE SAME MANAGER IS ALLOWED TO MANAGE EVEN AFTER REPEATED FAILURES. I ASK YOU TO TAKE THIS SERIOUSLY BECAUSE IT IS ABOUT PATIENT SAFETY. THIS HEALTH SYSTEM IS THE MAIN HEALTH SYSTEM FOR SEVERAL COUNTIES AND THIS SCARES ME FOR THE PATIENTS. ALSO PLEASE SPEAK WITH STAFF BECAUSE I AM AFRAID THAT LEADERSHIP WILL TRY TO COVER IT UP AND THIS IS VERY SERIOUS. THANK YOU FOR LOOKING INTO THIS. SINCERELY, A CONCERNED STAFF MEMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1681940 SOFTBANK SOFTDONOR VERSION 4.5.5 BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES MMH SCC SOFT COMPUTER

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown