BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNDEO SYRINGE PUMP

    MDR report key: 1496133 · Received October 8, 2009

    Report

    Report Number
    6000001-2009-01008
    Event Type
    Malfunction
    Date Received
    October 8, 2009
    Date of Event
    September 17, 2009
    Report Date
    September 18, 2009
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    MEA
    PMA / PMN Number
    K031566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). A BAXTER SERVICE TECHNICIAN EVALUATED THE PUMP AND COULD NOT CONFIRM THE CUSTOMER REPORTED CONDITION OF "OVERINFUSION". UPON COMPLETION OF BAXTER'S INVESTIGATION OF THIS REPORT, THE PUMP WILL BE ROUTED TO OUR SERVICE DEPARTMENT FOR THE APPROPRIATE SERVICING TO BE COMPLETED PRIOR TO BEING RETURNED TO THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CORRECT 510K, K031566. (B)(4).

    Additional Manufacturer Narrative · 1

    (B) (4). THIS DEVICE HAS BEEN RECEIVED IN BAXTER'S PRODUCT ANALYSIS LAB AND IS BEING EVALUATED. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE PT REPORTED THE INFUSION DEVICE MAKES NOISE DURING OPERATION. SHE STATED THAT ON (B) (6) 2010 SHE BEGAN TO FEEL ILL AND SHE VOMITED AFTER LUNCH AT 2:00 PM. HER BLOOD GLUCOSE MEASURED 1.9 MMOL/L (34 MG/DL). SHE WAS TAKEN BY AMBULANCE TO THE HOSPITAL. SHE STATED THAT SHE HAD NOT GIVEN HERSELF A BOLUS. HER NORMAL BLOOD GLUCOSE RANGE IS 4.5-10 MMOL/L (81-180 MG/DL). NO FURTHER INFO IS AVAILABLE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON SEPTEMBER 18, 2009, A BAXTER SERVICE REPRESENTATIVE NOTIFIED CORPORATE PRODUCT SURVEILLANCE THAT THE FACILITY HAS A SYNDEO SYRINGE PUMP THAT EXPERIENCED A POSSIBLE OVERINFUSION OF MORPHINE ON (B) (6) 2009. DURING PATIENT USE. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    CO2 WOULD NOT FLOW WITH FILTER ON. WOULD NOT WORK UNLESS FILTER WAS REMOVED.====================== HEALTH PROFESSIONAL'S IMPRESSION======================FILTER HAS "HOURGLASS" TAPERING LOOK TO IT, POSSIBLY HINDERING FLOW.====================== MANUFACTURER RESPONSE FOR LAPAROSCOPIC PACK, (B) (4) LAPAROSCOPIC PACK======================REP HAS BEEN CALLED AND HAS TAKEN SAMPLES FROM SISTER HOSPITAL AND WILL COME GET THIS SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNDEO SYRINGE PUMP PUMP, INFUSION, PCA MEA BAXTER HEALTHCARE - LARGO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1