BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP FREEDOM 60

    MDR report key: 14843716 · Received June 27, 2022

    Report

    Report Number
    MW5110550
    Event Type
    Malfunction
    Date Received
    June 27, 2022
    Date of Event
    June 19, 2022
    Report Date
    June 20, 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 PATIENT, REPORTED THAT DURING THEIR INFUSION ON (B)(6) 2022 AT 10PM THE PUMP MALFUNCTIONED (SERIAL NUMBER UNKNOWN). PATIENT STATED THEY WOULD NEED NEW PUMP FOR NEXT DAY TO FINISH INFUSION. PATIENT REPORTED THEY HAD 18GM LEFT TO INFUSE; MISSED DOSE. NO ADVERSE EVENT OCCURRED DUE TO MISSED DOSE. PATIENT WAS ADVISED THEY CANNOT USE LEFTOVER MEDICATION AND NEW REPLACEMENT MEDICATION WOULD BE SENT WITH THE PUMP. UNKNOWN IF MD IS AWARE. NO FURTHER INFORMATION, DETAILS OR DATES PROVIDED. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PATIENT? YES; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO; IS THE ACTUAL DEVICE AVAILABLE FOR INVESTIGATION? YES; DID WE REPLACE THE DEVICE? YES; DID THE PATIENT HAVE A BACKUP DEVICE THEY WERE ABLE TO USE? NO, WHICH CAUSED MISSED DOSE FREQUENCY: INFUSE 27GM (135ML) SUBCUTANEOUSLY DAILY FOR 2 DAYS EVERY 2 WEEKS. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703979 PUMP FREEDOM 60 PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male