BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP FREEDOM 60

    MDR report key: 14843747 · Received June 27, 2022

    Report

    Report Number
    MW5110552
    Event Type
    Malfunction
    Date Received
    June 27, 2022
    Date of Event
    June 8, 2022
    Report Date
    June 9, 2022
    Manufacturer
    REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SPONTANEOUS COMMUNICATION FROM THE PATIENT'S GIRLFRIEND WHO REPORTED THAT THE PATIENT'S INFUSION WAS DUE LAST NIGHT AND THE PUMP BROKE AGAIN. THE PATIENT RECEIVED A NEW PUMP 2 WEEKS AGO AND BROKE AGAIN. THE PATIENT'S GIRLFRIEND WAS ADVISED TO ASSESS THE PUMP "SIB.JATION" AND TO REWIND AT THE END OF THE INFUSION. THE PATIENT'S GIRLFRIEND REPORTED THAT THE PATIENT FOLLOWS THE CORRECT STEPS EVERY TIME HE INFUSES. THE PATIENT'S GIRLFRIEND REPORTED THAT WHEN SHE PUTS THE SYRINGE INSIDE THE PUMP, IT DOES NOT STAY AND BACKS OUT FROM THE POSITION. A NEW PUMP WILL BE SENT OUT AND PATIENT WILL SCHEDULE DELIVERY OF THE NEW PUMP. THERE WAS NO ADVERSE DRUG EVENT REPORTED BY PATIENT THE PATIENT DID NOT START HIS INFUSION ON THAT DAY. THE NEW PUMP WAS SENT TO THE PATIENT TO INFUSE THE MEDICATION ON THE NEXT DAY. THE PRODUCT FAULT DID NOT OCCUR WHILE IN USE AND THERE WAS NO CLINICAL INJURY REPORTED. THE PRODUCT LOT NUMBER AND EXPIRATION DATE ARE UNKNOWN. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703982 PUMP FREEDOM 60 PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male