BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRONO FIVE 2.5MG/ML

    MDR report key: 7995114 · Received October 22, 2018

    Report

    Report Number
    MW5080749
    Event Type
    Malfunction
    Date Received
    October 22, 2018
    Report Date
    October 8, 2018
    Manufacturer
    CANE S.R.L. MEDICAL TECHNOLOGY/INTRA PUMP INFUSION SYSTEM
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT INFORMED PHARMACY THAT CRONO PUMP FOR REMODULIN IV SERIAL NUMBER (B)(4) WAS ALARMING WITH NO ERROR MESSAGE. SHE TRIED SWITCHING BATTERIES BUT THAT DIDN'T HELP EITHER. PHARMACY WILL SEND HER A PUMP REPLACEMENT AND RETURN BOX FOR MALFUNCTIONING PUMP. SHE DID NOT MISS ANY THERAPY AS HER OTHER PUMP IS WORKING FINE. NO OTHER INFORMATION PROVIDED. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER. DOSE OR AMOUNT: 1.8NG/KG/MIN, FREQUENCY: CONTINUOUS, ROUTE: IV. DATES OF USE: FROM (B)(6) 2017 TO CURRENT. DIAGNOSIS OR REASON FOR USE: PAH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830326 CRONO FIVE 2.5MG/ML PUMP, INFUSION FRN CANE S.R.L. MEDICAL TECHNOLOGY/INTRA PUMP INFUSION SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1