BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6461500 INFUSOR PUMP (1 LABEL)

    MDR report key: 1628588 · Received March 11, 2010

    Report

    Report Number
    6000001-2010-00283
    Event Type
    Malfunction
    Date Received
    March 11, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 4, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K883577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF OVER DELIVERY WAS NOT CONFIRMED OR DUPLICATED. AN ACCURACY TEST WAS PERFORMED AND VALUES ARE WITHIN SPECIFICATION. THE INCORRECT 510K NUMBER WAS PROVIDED IN THE INITIAL MDR. THE CORRECT 510K NUMBER, K883577, HAS BEEN PROVIDED. (B) (4)

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REQUESTED FOR EVALUATION. SHOULD THE DEVICE BE RECEIVED AND AN EVALUATION PERFORMED, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S HYSTERECTOMY PROCEDURE, WHILE DISSECTING TISSUE, THE TIP OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT BROKE OFF AND FELL INTO THE PATIENT'S ABDOMEN. THE BROKEN PIECE WAS RETRIEVED AND THE PLANNED PROCEDURE WAS COMPLETED WITH A REPLACEMENT INSTRUMENT OF THE SAME TYPE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Description of Event or Problem · 1

    A BIOMED TECHNICIAN CALLED BAXTER TECHNICAL SERVICE ON 3/4/10. THE TECHNICIAN REPORTED AN INFUSOR PUMP THAT OVERINFUSED 60 ML EXTRA OUT OF 100 ML. DURING TESTING IN BIOMED. A PROPOFOL SMART LABEL WAS ON PUMP, DOSAGE WAS 100KG, WHEN CYCLE WAS FINISHED, IT WAS DISCOVERED THAT THE PUMP HAD DELIVERED AN ADDITIONAL 60 ML OF FLUID. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6461500 INFUSOR PUMP (1 LABEL) INFUSION, PUMP FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1