BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURLIN INFUSION IV PUMP

    MDR report key: 2973491 · Received February 14, 2013

    Report

    Report Number
    1722139-2013-00082
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    December 6, 2012
    Report Date
    January 14, 2013
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED. ATTEMPT WAS MADE TO FDA AND A RESPONSE RECEIVED THAT NO FURTHER INFORMATION ARE ALLOWED TO RELEASE. REF MEDWATCH (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM MEDWATCH (B)(4) STATED THAT A 6000 CURLIN INFUSION PUMP WORKED PROPERLY WHEN PLUGGED IN, BUT NOT WITH C-CELL BATTERIES AND PUMP CONTINUED TO ALARM LOW BATTERY OR MOTOR SEIZED CAUSING PT NEEDED TO CHANGE THE BATTERIES FIVE TIMES DURING 12 HOURS INFUSION. AT ONE POINT, THE PUMP STOPPED COMPLETELY TIMES 40 MINUTES RESULTING IN A DROP IN BLOOD GLUCOSE INTO THE 50'S WHICH THEN RESULTED IN A TRIP TO THE EMERGENCY ROOM WHERE IT TOOK A COUPLE OF HOURS FOR THE BLOOD GLUCOSE TO RECOVER. PUMP SETTINGS WERE 1800 ML BAG VOLUME, 1700 ML AMOUNT TO BE INFUSED, 12 HOURS, 1 HOUR RAMP, AND 154.5 ML/HR RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66244 CURLIN INFUSION IV PUMP FRN MOOG MEDICAL DEVICES GROUP 6000 CMS IOD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization TPN