BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1810531 · Received August 21, 2010

    Report

    Report Number
    6000001-2010-02688
    Event Type
    Malfunction
    Date Received
    August 21, 2010
    Date of Event
    July 30, 2010
    Report Date
    July 30, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO USE OR USER ERROR ASSOCIATED WITH THIS REPORT. THERE HAVE BEEN SIMILAR COMPLAINTS REPORTED TO BAXTER. THE ROOT CAUSE FOR THIS ISSUE IS CURRENTLY BEING INVESTIGATED THROUGH CAPA (CORRECTIVE AND PREVENTIVE ACTION) INVESTIGATION (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE ASSIGNABLE CAUSE WAS A DEFECTIVE CHANNEL A PHM (PUMPHEAD MODULE) KEYPAD. THE CHANNEL A PHM KEYPAD HAS BEEN REPLACED.A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE GENERAL BILE DUCT PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DISTAL TIP OF THE GUIDEWIRE DETACHED IN THE INTESTINE OF THE PATIENT. NO ATTEMPT WAS MADE TO RETRIEVE THE FRAGMENT; THE PHYSICIAN BELIEVED IT WOULD PASS NATURALLY. ANOTHER JAGWIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    DURING BAXTER DEVICE EVALUATION, THE CHANNEL A CHANNEL SELECT KEY WAS DISCOVERED TO BE INOPERATIVE. THERE WAS NO DOCUMENTED PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.THE USER INTERFACE MODULE MASTER SOFTWARE VERSION FOR THIS DEVICE IS 5.04.00, CATEGORIZED AS UNREMEDIATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1