BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1460824 · Received September 2, 2009

    Report

    Report Number
    6000001-2009-00863
    Event Type
    Malfunction
    Date Received
    September 2, 2009
    Date of Event
    August 1, 2009
    Report Date
    August 25, 2009
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE CONDITION OF INOPERABLE STOP KEY COULD NOT BE CONFIRMED. HOWEVER THE CONDITION OF INOPERABLE OPEN KEY WAS CONFIRMED, DUE TO A CUT OPEN KEY CIRCUIT TRACE ON THE PUMPHEAD MODULE (PHM) KEYPAD. (B) (4)

    Additional Manufacturer Narrative · 1

    THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE (B) (4) CATEGORIZED AS COLLEAGUE 2006. (B) (4)

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED CONDITION OF OPEN KEY AND THE STOP KEY DOES NOT FUNCTION WAS CONFIRMED THROUGH EVALUATION. UPON THE COMPLETION OF BAXTER'S INVESTIGATION OF THIS REPORT, THE PUMP WILL BE ROUTED TO OUR SERVICE DEPARTMENT WHERE APPROPRIATE SERVICING WILL BE COMPLETED PRIOR THE PUMP BEING RETURNED TO THE CUSTOMER. (B) (4)

    Additional Manufacturer Narrative · 1

    A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. THERE IS AN ONGOING CAPA INVESTIGATION, (B) (4) ASSOCIATED WITH THIS REPORT. (B) (4)

    Description of Event or Problem · 1

    NOTE: THIS MFR REPORT PERTAINS TO ONE OF SIX DEVICE COMPLAINTS REPORTED TO OCCUR DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT #3005099803-2009-03832, #3005099803-2009-03833, #3005099803-2009-03835, #3005099803-2009-03836, AND #3005099803-2009-03837 FOR A DESCRIPTION OF THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT SIX RESOLUTION CLIP DEVICES WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2009. ACCORDING TO THE COMPLAINANT, DURING THE CASE, SIX CLIPS USED IN THE CASE WOULD NOT COME OUT OF THE PLASTIC PROTECTIVE COVERING. THEY PULLED THE BLUE HANDLE AS FAR AS THE HANDLE WOULD GO, AND THE SHEATH WOULD NOT PULL BACK FAR ENOUGH TO EXPOSE EACH CLIP. THEY FINISHED THE CASE WITH A COMPETITORS DEVICE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PT'S CONDITION WAS REPORTED TO BE "FINE."

    Description of Event or Problem · 1

    ON AUGUST 25, 2009, THE FACILITY'S BIOMEDICAL ENGINEER REPORTED TO BAXTER GLOBAL TECHNICAL SERVICES THAT ON AN UNKNOWN DATE ONE COLLEAGUE CX VOLUMETRIC INFUSION PUMP IN WHICH THE OPEN KEY AND THE STOP KEY DID NOT FUNCTION. THIS EVENT OCCURRED WHEN TURNING ON THE PUMP DURING BIOMED TESTING. IT WAS INDICATED THAT THE PUMP HAD BEEN RECEIVED WITH A NOTE ATTACHED STATING "DOES NOT WORK" AND THAT TUBING WAS NOT ABLE TO BE LOADED INTO THE PUMP. NO AUDIBLE/VISIBLE ALARMS OR FAILURE CODES OCCURRED. THE LAST DATE THAT THE PUMP WAS SERVICED WAS JULY 02 2009. NO OTHER FACILITY OTHER THEN BAXTER HAS SERVICED THIS PUMP. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THIS DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT A LEAK FROM THE CASSETTE WAS OBSERVED WHEN THE SET WAS REMOVED FROM A YUME MACHINE. THERE WAS NO PATIENT INJURY / MEDICAL INTERVENTION. THE ACTUAL SAMPLE IS AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A VENTED ELECTRIC LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PT HAD BEEN EXPERIENCING SHORTNESS OF BREATH (SOB) FOR APPROX TWO WEEKS, AND AS A RESULT, REQUIRED AORTIC AND TRICUSPID VALVE REPAIR SECONDARY TO SEVERE AORTIC INSUFFICIENCY/TRICUSPID REGURGITATION AND SOB. DURING THE SURGERY TO REPAIR THE VALVES, THE HOSPITAL MADE A DECISION TO EXCHANGE THE LVAD WITH ANOTHER LVAD AS THE PT WAS 17 MONTHS POST-IMPLANT, AND DEVICE END OF LIFE WAS SUSPECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1