BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM 60

    MDR report key: 8249111 · Received January 11, 2019

    Report

    Report Number
    MW5083109
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Report Date
    January 7, 2019
    Manufacturer
    RMS MEDICAL PRODUCTS
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPOKE WITH PT, STATES THAT INFUSIONS STARTED AROUND 1 HR 40 MIN WHEN HE FIRST STARTED, BUT LAST 3-4 INFUSIONS HAS TAKEN OVER 2 HOURS. REVIEWED PUMP MAY NEED MAINTENANCE AND WE CAN SEND A REPLACEMENT PUMP WITH HIS NEXT ORDER. HE WAS FINE WITH THIS, ALSO REVIEWED, HAS BEEN HAVING DISCOMFORT AT INFUSION SITES. SPOKE WITH HIS MD WHO SUGGESTED THAT HE TAKE A ZYRTEC AND USE COLD COMPRESS WHICH HAS HELPED, BUT ALSO THOUGHT HE SHOULD TRY A SHORTER NEEDLE. HE'S ALREADY USING STANDARD FOR AVG ADULTS, "BUT REVIEWED THAT PT Q - ITS ISA-I - ABDOMEN AREA WHERE HE INFUSES. REVIEWED, WE CAN SEND 6MM NEEDLE SETS WITH NEXT ORDER, BUT INSTRUCTED TO MONITOR FOR AND REPORT EATING, WOULD LIKE SHORTER 6MM NEEDLE PER HIS DISCUSSION WITH HIS MD. NO ADVERSE EVENT WAS REPORTED." REPORTED TO (B)(6) BY PT/CAREGIVER. DOSE OR AMOUNT: 20GM (100ML), FREQUENCY: EVERY 2 WEEKS, ROUTE: SUBCUTANEOUSLY. DATES OF USE: FROM UNK TO CURRENT. DIAGNOSIS OR REASON FOR USE: NONFAMILIAL HYPOGAMMAGLOBULINEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35539 FREEDOM 60 PUMP, INFUSION FRN RMS MEDICAL PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1