BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNDEO SYRINGE PUMP

    MDR report key: 1532065 · Received November 18, 2009

    Report

    Report Number
    6000001-2009-01204
    Event Type
    Malfunction
    Date Received
    November 18, 2009
    Date of Event
    October 16, 2009
    Report Date
    October 26, 2009
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FRN
    PMA / PMN Number
    K926385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4)

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. (B) (4)

    Description of Event or Problem · 1

    ON OCTOBER 26, 2009, THE FACILITY'S BIOMEDICAL ENGINEER REPORTED TO BAXTER GLOBAL TECHNICAL SERVICES THAT ON (B) (6), 2009 ONE SYNDEO SYRINGE PUMP IN WHICH THE PATIENT FELT SICK AFTER RECEIVING 25MCG OF FENTANYL IN 15 MINUTES WITHOUT PRESSING BUTTON FOR EXTRA DOSE, ALSO THE NURSE MENTIONED THAT THE PUMP GAVE 4MCG RIGHT AWAY WHEN SHE FIRST STARTED THE PUMP. IT IS SUSPECTED THE PUMP WAS NOT SET UP CORRECTLY. THE FACILITY'S PHARMACY TECHS WENT TO THE PATIENT?S ROOM TO CHECK PUMP SETTING, WHICH WERE SET UP CORRECTLY AS ORDERED. DOSAGE PCA DOSE 13MCG DELAY 15MINUTES, CONTINUOUS 50MCG PER HOUR, ONE HOUR LIMIT AND 102MCG AND NO BOLUS. THERE WAS NO MEDICAL INTERVENTION OR PATIENT INJURY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE ORTHO SUMMIT SAMPLE HANDLING SYSTEM INSTRUMENT DID NOT PIPETTE THE CORRECT AMOUNT OF SAMPLE AND REAGENT AND DID NOT GENERATE AN ERROR MESSAGE.NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNDEO SYRINGE PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1