BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN INFUSION PAINSMART IOD IV PUMP

    MDR report key: 1508452 · Received October 14, 2009

    Report

    Report Number
    1722139-2009-00041
    Event Type
    Malfunction
    Date Received
    October 14, 2009
    Date of Event
    September 9, 2009
    Report Date
    October 13, 2009
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP WILL NOT BE RETURNED TO MOOG MEDICAL DEVICES GROUP PER THE CUSTOMER. THE CUSTOMER'S BIOMED DEPARTMENT TESTED THE PUMP WITH THE SAME SYRINGE TYPE AND COULD NOT DUPLICATE THE ERROR. IT APPEARS THE CAREGIVERS ARE TWISTING THE SYRINGES, CAUSING THEM TO NOT FUNCTION AS DESIGNED.

    Description of Event or Problem · 1

    REPORTED BY THE CUSTOMER AS: "NURSES AT (B)(6) HOSPITAL ARE EXPERIENCING UNDER INFUSIONS WITH B-D SYRINGES FILLED BY THE PHARMACY. FIFTY-FIVE ML PROGRAMMED AND 10ML LEFTOVER AFTER THE PUMP COMPLETES ITS DOSE. PUMP WILL NOT BE RETURNED. BIOMED CHECKING PUMP WITH NEW SYRINGES AND CANNOT DUPLICATE ERROR. NURSES STATE THEY WERE TWISTING THE SYRINGE'S PLUNGER". PATIENT INJURY? NO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1