BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CXE VOLUMETRIC INFUSION PUMP SINGLE CHANNEL RECERT

    MDR report key: 1765757 · Received July 21, 2010

    Report

    Report Number
    6000001-2010-01854
    Event Type
    Malfunction
    Date Received
    July 21, 2010
    Date of Event
    February 19, 2010
    Report Date
    July 12, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING A REVIEW OF THE EVENT HISTORY, THE OCCURRENCE DATE IS (B)(6) 2010. THERE IS A CAPA (CORRECTIVE AND PREVENTIVE ACTION) INVESTIGATION ASSOCIATED WITH THIS REPORT, MDQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    DURING SERVICE AT BAXTER, A TECHNICIAN REPORTED A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 810:11THAT WAS CAUSED BY THE AIL PCB (AIR IN LINE PRINTED CIRCUIT BOARD) THAT WAS OUT OF CALIBRATION AND WAS RECALIBRATED BY SERVICE. THE FACILITY REPRESENTATIVE STATED THAT THERE WERE NO REPORTS OF PATIENT INJURY, ADVERSE EVENT OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION FOR THIS DEVICE (B)(4) CATEGORIZED AS REMEDIATED.

    Description of Event or Problem · 1

    DURING A PATIENT CHOLECYSTECTOMY PROCEDURE, THE SURGEON INSERTED, THROUGH THE SAME INCISION CUT AS THE SPIDER DEVICE, A RIGID SUCTION/IRRIGATION INSTRUMENT. THE SURGEON ACCIDENTALLY TANGLED THE SUCTION/IRRIGATION INSTRUMENT INTO THE SPIDER DEVICE AND BROKE OR SNAPPED LOOSE THE UPPER RIGHT LINK ARM AT THE LINK ARM CONNECTOR. A PIECE OF THE LINK ARM CONNECTOR FELL INTO THE SURGICAL BED. THE SURGEON WAS ABLE TO LOCATE AND RETRIEVE THE PIECE FROM THE PATIENT. NO INJURY OR IMPACT TO PATIENT CARE WAS REPORTED. THE DEVICE WAS RETURNED TO TRANSENTERIX, INC. FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP SINGLE CHANNEL RECERT PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1