BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1692723 · Received May 18, 2010

    Report

    Report Number
    6000001-2010-00574
    Event Type
    Malfunction
    Date Received
    May 18, 2010
    Date of Event
    May 6, 2010
    Report Date
    May 6, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-12/108-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. HOWEVER, THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION AS OF YET. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE IS ALREADY A REPORT OPENED TO CAPTURE THE VISIBLE SMOKE, 6000001-2010-00573. THIS REPORT WILL ONLY CAPTURE FAILURE CODE 701. THIS REPORT IS NO LONGER REPORTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND EVALUATED BY BAXTER. THE REPORTED CONDITION WAS NOT CONFIRMED AND NOT DUPLICATED. THE MOST LIKELY ASSIGNABLE CAUSE IS SHORTED J1 SOCKET ON THE PUMPHEAD DISPLAY PRINTED CIRCUIT BOARD CABLE ASSEMBLY. 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. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION FOR THIS DEVICE IS 5.09.90, CATEGORIZED AS REMEDIATED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE FOR THIS ISSUE IS CURRENTLY BEING INVESTIGATED THROUGH CAPA (CORRECTIVE AND PREVENTIVE ACTION) INVESTIGATION (B)(4).

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER ON (B)(6) 2010 TO REPORT A COLLEAGUE INFUSION PUMP IN WHICH ON (B)(6) 2010 VISIBLE SMOKE CAME FROM THE CHANNEL WHEN THE PUMP WAS OPENED TO LOAD THE TUBING. THE EVENT OCCURRED DURING BIOMEDICAL TESTING. THERE IS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THE SOFTWARE VERSION OF THIS DEVICE IS CURRENTLY UNKNOWN.THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A RESOLUTION CLIP DEVICE WAS USED. ACCORDING TO THE COMPLAINANT, "THE TIP WAS OFF THE CLIP WHEN IT WAS OPENED". SEVERAL ATTEMPTS TO ASCERTAIN FURTHER DETAILS (INCLUDING PATIENT INFORMATION AND FOLLOW-UP PROCEDURE INFORMATION) HAVE BEEN UNSUCCESSFUL TO DATE. IT CANNOT BE DETERMINED IF THE COMPLAINANT CONTENDS THAT THE RESOLUTION CLIP WAS DEPLOYED IN AN OPEN STATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO LEAKING FROM VACUUM HOSE ON EXHAUST WASTE INTAKE AND BACK OF SYNCHRON CX5 DELTA CLINICAL SYSTEM. CUSTOMER TECHNICAL SUPPORT CAUTIONED CUSTOMER THAT MATERIAL COULD BE BIOHAZARDOUS. THE CUSTOMER VERIFIED THAT THE VACUUM CANISTER IS FULL. NO BIOHAZARD EXPOSURE OR INJURY WAS REPORTED. THERE WAS NO EFFECT TO PATIENT OR USER.

    Description of Event or Problem · 1

    BASED ON THE REPORT, THE PRODUCT WAS RETURNED AS AN IMPLANT FAILURE BECAUSE OF LACK OF OSSEOINTEGRATION. BASED ON THE REPORT, THE PT HAD GOOD ORAL HYGIENE AND GOOD BONE CONDITION. THE FIXTURE WAS PLACED WITH TRADITIONAL TWO STAGE SURGERY IN TOOTH LOCATION #20. NO BONE MATERIAL WAS USED. THE DOCTOR INDICATED THAT THE DEVICE WAS NOT RECEIVED DAMAGED OR DEFECTIVE SUCH THAT IT WOULD NOT PERFORM AS INTENDED. THE PT OUTCOME WAS REPORTED AS RECOVERED, NO COMPLICATIONS.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1