BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRONO INFUSION PUMP

    MDR report key: 7521625 · Received May 16, 2018

    Report

    Report Number
    MW5077269
    Event Type
    Malfunction
    Date Received
    May 16, 2018
    Date of Event
    May 9, 2018
    Report Date
    May 9, 2018
    Manufacturer
    CANE SPA MEDICAL TECHNOLOGY
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    (B)(4) FROM PATIENT REPORTING A PUMP PROBLEM. PUMP WAS IN USE AS USUAL WHEN ERROR SCREEN SAID THERE WAS OCCLUSION. I EXPLAINED THAT SHE SHOULD DISCONNECT AND RECONNECT, BUT SHE STATED SHE UNDID ALL THE PARTS AND EVEN REMOVED AND REINSERTED BATTERY AND IT STILL SAID OCCLUSION. WHEN SHE SWITCHED TO HER OTHER PUMP, IT WORKED PERFECTLY FINE. TOLD PATIENT WE CAN REPLACE PUMP (S/N (B)(4)). DATES OF USE: (B)(6) 2017 TO ONGOING. DIAGNOSIS OR REASON FOR USE: PAH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363429 CRONO INFUSION PUMP CRONO 6 INFUSION PUMP FRN CANE SPA MEDICAL TECHNOLOGY

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR