BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRONO-5 PUMP

    MDR report key: 8612505 · Received May 14, 2019

    Report

    Report Number
    MW5086652
    Event Type
    Malfunction
    Date Received
    May 14, 2019
    Report Date
    April 30, 2019
    Manufacturer
    INTRA PUMP INFUSION SYSTEMS
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PER PT, CRONO PUMP SERIAL # (B)(4) DOES NOT WORK. WHEN SHE GOES TO PRIME IT, IT JUST SAYS "ERROR" AND JUST BEEPS AND DOES NOT RUN. SHE TRIED TO CHANGE THE BATTERIES AND IT STILL DOESN'T WORK. SENDING HER ANOTHER PUMP TO REPLACE THAT ONE SO THAT SHE HAS TWO WORKING PUMPS ON HAND PRIOR TO TRANSITION TO LEGACY PUMP ON FRIDAY. PT WILL RETURN BROKEN PUMP TO US. SWITCHED TO BACKUP PUMP. WITHOUT ISSUES OR HARM TO PT, NO FURTHER INFO AVAILABLE. REPORTED (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403550 CRONO-5 PUMP PUMP, INFUSION FRN INTRA PUMP INFUSION SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1