BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP FREEDOM 60

    MDR report key: 14084263 · Received April 11, 2022

    Report

    Report Number
    MW5108885
    Event Type
    Malfunction
    Date Received
    April 11, 2022
    Report Date
    March 14, 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

    PATIENT'S MOTHER REPORTED ISSUES WITH PUMP. MOTHER STATED PUMP HAS NOT BEEN WORKING. STOPPED DURING LAST INFUSION AND HAD TO FINISH WITH MANUAL INFUSION. PHARMACY WILL SEND NEW PUMP FOR REPLACEMENT. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PT? YES; THIS DID OCCUR DURING PT USE, BUT PT WAS ABLE TO INFUSE MEDICATION WITHOUT PUMP. IS THE ACTUAL DEVICE AVAILABLE FOR INVESTIGATION? YES; DID WE [MFR] REPLACE THE DEVICE? YES; DID THE PT HAVE A BACKUP DEVICE THEY WERE ABLE TO SWITCH TO? YES; PT MANUALLY SLOWLY PUSHED THE SYRINGE. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788449 PUMP FREEDOM 60 PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS F10050 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Female