BEUDAMED
    FDA Adverse Event Other Summary report: N

    CURLIN INFUSION 4000 PLUS IV PUMP

    MDR report key: 1642587 · Received March 24, 2010

    Report

    Report Number
    1722139-2010-00034
    Event Type
    Other
    Date Received
    March 24, 2010
    Date of Event
    February 23, 2010
    Report Date
    March 22, 2010
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: PUMP HISTORY LOG WAS REVIEWED. RESULTS: STANDARD PERFORMANCE TESTS WERE COMPLETED, WHICH INCLUDES ACCURACY TESTING. CONCLUSION: PERFORMANCE TESTS COULD NOT DUPLICATE THE UNINTENDED BOLUS. APPEARS IT MAY HAVE BEEN THE DEVICE OPERATOR THAT PROGRAMMED ADDITIONAL BOLUS DOSES. REVIEW OF THE HISTORY LOG SHOWS THIS PUMP HAS NOT BEEN USED SINCE ITS MFG DATE IN 2006 AND HAS A TOTAL VOLUME DELIVERED OF 0ML. THIS PUMP HAS NEVER BEEN RUN. IT IS LIKELY THAT THIS IS NOT THE PUMP USED DURING THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    REPORTED BY THE CUSTOMER AS: ANESTHESIOLOGIST ATTEMPTED TO DELIVER CLIN DOSE, INSTEAD ELECTED TO GIVE A BOLUS DOSE. ABOUT 15-20 MINS LATER SHOWED THE PUMP HAD DELIVERED 3 OF THE 5 DOSES. MEDICAL INTERVENTION WAS USED. PT BECAME LETHARGIC AND HYPOTENSIVE WITH BP GOING DOWN TO 70/40. RECEIVED O2 10ML PER MASK. PT DID NOT REQUIRE AN EXTENDED STAY. PT HAD SUCCESSFUL VAGINAL DELIVERY, NO HARM TO INFANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1