BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP FREEDOM 60

    MDR report key: 10211858 · Received June 29, 2020

    Report

    Report Number
    MW5095286
    Event Type
    Malfunction
    Date Received
    June 29, 2020
    Report Date
    June 22, 2020
    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

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS INBOUND CALL FROM PATIENT WHO REPORTED THAT HER PUMP MALFUNCTIONED WITH THE LAST INFUSION AND TWO 4-GRAM VIALS WERE WASTED; PATIENT LOADED MEDICATION FROM NEW VIALS INTO A DIFFERENT SYRINGE, SO NO DOSE WAS MISSED, BUT PATIENT WILL NOT HAVE FULL DOSE FOR NEXT MONDAY, SO NEEDS REPLACEMENT; NO ADVERSE EVENTS REPORTED; NOT SPECIFIED IF PATIENT HAS WASTED PRODUCT/VIALS ON HAND, BUT RETURN BOX WAS SENT TO PATIENT TO RETURN PUMP; LOT NUMBER AND EXPIRATION DATES NOT PROVIDED; NO FURTHER INFORMATION. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER. DATES OF USE: FROM (B)(6) 2018 TO CURRENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674392 PUMP FREEDOM 60 PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1