BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRONO FIVE

    MDR report key: 6646109 · Received June 16, 2017

    Report

    Report Number
    3003098013-2017-00011
    Event Type
    Malfunction
    Date Received
    June 16, 2017
    Date of Event
    March 21, 2017
    Report Date
    May 19, 2017
    Manufacturer
    CANÈ S.P.A.
    Product Code
    FRN
    PMA / PMN Number
    K052218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE CHECKED THE PUMP, WHICH WAS FOUND WORKING ACCORDING TO ITS SPECIFICATIONS AND INTENDED USE. NO EVIDENCE OF MALFUNCTION WAS FOUND BY SERVICE, WHICH PROCEEDED WITH THE REGULAR MAINTENANCE SERVICE. NO CONSEQUENCES FOR THE PATIENT.

    Additional Manufacturer Narrative · 1

    WE BECAME AWARE OF THIS EVENT DURING POST-MARKET SURVEILLANCE THROUGH RESEARCH ON MAUDE DATABASE (REPORT NUMBER MW5068678). WE ASKED OUR DISTRIBUTOR TO RECEIVE FURTHER INFORMATION AND THE AVAILABILITY OF THE PUMP FOR THE ACTUAL EVALUATION. AS SOON AS THE PUMP IS EVALUATED, A FOLLOW-UP REPORT WILL BE SENT. NO CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 1

    WE BECAME AWARE, DURING POST-MARKET SURVEILLANCE, OF AN EVENT REPORTED ON MAUDE DATABASE (REPORT NUMBER MW5068678) OF WHICH WE HAD NOT BEEN MADE PREVIOUSLY AWARE. EVENT DESCRIPTION: 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 (B)(6) 2014 TO CURRENT. DIAGNOSIS OR REASON FOR USE: PAH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428166 CRONO FIVE AMBULATORY INFUSION PUMP FRN CANÈ S.P.A. CRONO FIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR