BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRONO 5 PUMP

    MDR report key: 6438735 · Received March 24, 2017

    Report

    Report Number
    MW5068678
    Event Type
    Malfunction
    Date Received
    March 24, 2017
    Date of Event
    March 21, 2017
    Report Date
    March 21, 2017
    Manufacturer
    CANE'S P.A.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT STATES ONE OF HER INFUSION CRONO PUMPS IS GETTING AN OCCLUSION ERROR THAT CANNOT BE CLEARED. NEW PUMPS WERE SENT - THERE IS NO STOP IN PATIENTS THERAPY. SN#: (B)(4) DOSE OR AMOUNT: 8 NG/KG/M. FREQUENCY: CONTINUOUS. ROUTE: IV. DATES OF USE: FROM 10/30/2014 TO CURRENT. DIAGNOSIS OR REASON FOR USE: PAH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216648 CRONO 5 PUMP INFUSION PUMP FRN CANE'S P.A.
    216649 CRONO 5 PUMP CRONO INFUSION PUMP FRN CANE'S P.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR