BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRONO FIVE PUMP

    MDR report key: 6063642 · Received October 25, 2016

    Report

    Report Number
    MW5065673
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    October 7, 2016
    Report Date
    October 7, 2016
    Manufacturer
    CANE SPA MEDICAL TECHNOLOGY
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INBOUND CALL FROM PATIENT, HER CRONO 5 PUMP IS ALARMING OCCLUSION, PER PATIENT ALL CLAMPS ARE OPEN AND TUBING IS NOT KINKED. ATTEMPT MADE TO CHANGE JUST THE TUBING. HOWEVER WHEN PRESSING CORRECT BUTTONS TO PRIME AND ERROR 4 OCCURRED, THEN AND ERROR 5. PT SWITCHED TO BACK UP PUMP. NO PATIENT RELATED ADVERSE EVENT RELATED TO PUMP ERROR. NO MISSED DOSE. SENDING OUT A REPLACEMENT PUMP TO THE PATIENT. DOSE OR AMOUNT: 50.1 NG/KG/MIN. FREQUENCY: CONTINUOUS. ROUTE: IV. DATES OF USE: FROM (B)(6) 2013 TO ONGOING. DIAGNOSIS OR REASON FOR USE: PAH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707152 CRONO FIVE PUMP CRONO FIVE PUMP FRN CANE SPA MEDICAL TECHNOLOGY

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR