BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRONO FIVE

    MDR report key: 7066920 · Received November 29, 2017

    Report

    Report Number
    MW5073625
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Date of Event
    October 10, 2017
    Report Date
    October 10, 2017
    Manufacturer
    INTRA PUMP INFUSION SYSTEMS
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    IBC FROM PATIENT REGARDING CRONO PUMP; STATES SN # (B)(4) WAS ALARMING WITH "OCCLUSION" ERROR MESSAGE. STATES SHE THOUGHT IT WAS A TUBING ISSUE BUT THE ALARM WENT OFF AGAIN IN ABOUT 5 HOURS. PT SWITCHED TO A NEW PUMP USING SAME LINE AND NO OCCLUSION ALARM. WILL SEND THIS PUMP BACK ALONG WITH THE OTHER THAT'S DUE FOR MAINTENANCE, STATES SHE ALREADY HAD 2 FUNCTIONING PUMPS ON HAND (1 NEW PUMP WAS SENT LAST SHIPMENT). NO SE RESULTED FROM THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845990 CRONO FIVE PUMP, INFUSION FRN INTRA PUMP INFUSION SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR