BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM 60 PUMP

    MDR report key: 15579816 · Received October 7, 2022

    Report

    Report Number
    MW5112517
    Event Type
    Malfunction
    Date Received
    October 7, 2022
    Report Date
    August 22, 2022
    Manufacturer
    REPRO MED SYSTEMS, INC.
    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. PT CALLED IN TO REPORT THAT HER PUMP BROKE AND SHE NEEDS A NEW ONE FOR TOMORROW. UNKNOWN IF ADVERSE EVENT OCCURRED, NO MISSED DOSE. UNKNOWN IF SHE HAS DEVICE ON HAND FOR RETURN TO MANUFACTURER. UNKNOWN IF MD IS AWARE. NO FURTHER INFORMATION. INDICATION: CHRONIC INFLAMMATORY DEMYELINATING POLYNEURITIS. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PATIENT? NOT REPORTED/UNKNOWN; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? UNKNOWN IF ADVERSE EVENT OCCURRED; DID WE REPLACE THE DEVICE? DEVICE REPLACED; DID THE PATIENT HAVE A BACKUP DEVICE THEY WERE ABLE TO SWITCH TO? DEVICE REPLACED. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2943083 FREEDOM 60 PUMP PUMP, INFUSION FRN REPRO MED SYSTEMS, INC. F10050

    Patients

    Seq Age Sex Outcome Treatment
    1 Female