BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRONO 5 SYRINGE PUMP

    MDR report key: 9769940 · Received February 27, 2020

    Report

    Report Number
    MW5093373
    Event Type
    Malfunction
    Date Received
    February 27, 2020
    Report Date
    February 18, 2020
    Manufacturer
    INTRA PUMP INFUSION SYSTEM / CANE' S.P.A.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PER SPONTANEOUS CALL FROM PT, HER CRONO PUMP SN (B)(4) IS GIVING AN "ERROR ALARM". I WAS ABLE TO TROUBLESHOOT IT WITH HER ON THE PHONE, BUT SHE WANTS US TO SEND A NEW PUMP. SENDING FOR TOMORROW. SHE WILL RETURN THE "BROKEN" PUMP TO US. NO HARM TO PT. SHE HAS BEEN USING HER BACKUP PUMP. NO FURTHER INFO AVAILABLE. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230369 CRONO 5 SYRINGE PUMP PUMP, INFUSION FRN INTRA PUMP INFUSION SYSTEM / CANE' S.P.A.

    Patients

    Seq Age Sex Outcome Treatment
    1