BEUDAMED
    FDA Adverse Event Other Summary report: N

    CURLIN INFUSION 4000CMS IV PUMP

    MDR report key: 2623083 · Received June 14, 2012

    Report

    Report Number
    1722139-2012-00787
    Event Type
    Other
    Date Received
    June 14, 2012
    Date of Event
    May 1, 2012
    Report Date
    May 30, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING DID NOT CONFIRM THE COMPLAINT. FOUND CORRODED PCB.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES THAT THE PUMP HAD BEEN OFF FOR AT LEAST TWELVE HOURS WITH NO AUDIBLE ALARM HEARD. PT WENT TO THE PHYSICIAN'S OFFICE WHO TOLD HIM HE WENT HEART FAILURE. TREATED IN THE DOCTOR'S OFFICE AND IS FINE NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN INFUSION 4000CMS IV PUMP FRN MOOG MEDICAL DEVICES GROUP 4000CMS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR PRIMACOR