BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP FREEDOM 60

    MDR report key: 20842904 · Received December 3, 2024

    Report

    Report Number
    MW5163095
    Event Type
    Malfunction
    Date Received
    December 3, 2024
    Report Date
    November 26, 2024
    Manufacturer
    REPRO-MED SYSTEMS, INC. / KORU MEDICAL 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

    PT REPORTED THAT WHEN SHE WENT TO INFUSE HER HIZENTRA, THE MEDICATION LEAKING/EXPLODED OUT OF THE PUMP SYRINGE. SHE DID NOT GET ANY OF THE MEDICATION. THE MEDICATION WAS EVERYWHERE, ON HER CLOTHES, ON THE FLOOR IN THE PUMP, MAKING THE PUMP UNUSABLE. SHE NOTICED A CRACK IN THE TUBING AS WELL. SHE ALSO FELT THAT THE CONNECTORS DID NOT HOLD A TIGHT FIT. SHE ASKED IF THE PRESSURE IN THE TUBING CAUSED THE LEAKAGE TOO. ADVISED PT THAT CHANGING FLOW RATE/PRESSURE WOULD AFFECT INFUSION TIME. PT STATED SHE IS OK WITH KEEPING THE SAME FLOW RATE F2400 TUBING. ADVISED PT THAT WE WILL CONTACT HER MD TO NOTIFY OF MISSED CBSE, RESHIP DOSE THAT SPILLED (75ML DOSE), SEND A NEW PUMP, TUBING AND CONNECTORS. PHARMACY REPLACING DEVICE. NO ADVERSE EVENT(S) REPORTED DUE TO PRODUCT ISSUE. TROUBLESHOOTING WAS NOT REPORTED. DEVICE IS AVAILABLE FOR RETURN. TUBING, CONNECTORS, MEDICATION ARE UNKNOWN IF AVAILABLE FOR RETURN AS NOT REPORTED. NO ADDITIONAL INFO. SERIAL / LOT NUMBERS / EXPIRATION DATES FOR ALL SUPPLIES ARE UNK AS NOT REPORTED. REF REPORT: MW5163096.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1942752 PUMP FREEDOM 60 PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC. / KORU MEDICAL SYSTEMS INC. F10050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female CONNECTOR RAPID FILL L/L. | HIZENTRA 20% (4GM TOTAL).| HIZENTRA 20% PFS (10GM TOTAL).| HIZENTRA 20% PFS (1GM TOTAL).| LIDOCAINE / PRILOCAINE CRM.| TUBING FREEDOM 60 SYRINGE.| TUBING FREEDOM 60.