BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1801162 · Received August 16, 2010

    Report

    Report Number
    6000001-2010-02589
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 23, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY:THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 808:02 WAS CONFIRMED DURING PRODUCT EVALUATION. THIS CONDITION WAS CAUSED BY A FAULTY PUMPHEAD MODULE. THIS PUMP IS A BAXTER OWNED DEVICE AND WILL NOT BE REPAIRED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT 3005099803-2010-05216 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION CLIP DEVICES HAD ISSUES WHEN USED IN THE STOMACH DURING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE PERFORMED ON (B)(6) 2010. IT WAS INITIALLY REPORTED WHEN THE PACKAGES OF THE TWO CLIPS WERE OPENED, THERE WERE NO CLIPS PRESENT ON EITHER DEVICE OR IN ITS PACKAGING AND THERE WAS NO DAMAGE TO EITHER PACKAGING NOTED. FURTHER INFORMATION RECEIVED FROM THE COMPLAINANT ON (B)(6) 2010, WHICH IS CONTRARY TO WHAT WAS INITIALLY REPORTED, REVEALED THE FOLLOWING: THE CLIPS WERE PRESENT ON BOTH DEVICES. THE COMPLAINANT ATTEMPTED TO REMOVE THE OVER SHEATH FROM BOTH DEVICES AND EXCESSIVE FORCE WAS REQUIRED. THE COMPLAINANT REPORTED THAT IT WAS "AS IF THE CLIP WAS GLUED TO THE INSIDE OF THE OVER SHEATH." AFTER REMOVING THE SHEATH FROM THE DEVICES, BOTH CLIPS APPEARED TO BE BROKEN AND THAT A PIECE OF THE CLIP WAS MISSING ON BOTH DEVICES. ANOTHER RESOLUTION CLIP WAS USED FROM A DIFFERENT LOT TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT REMAINED WITHIN THE HOSPITAL FOR OBSERVATION BUT WAS DISCHARGED WITHIN 24 HOURS OF THE PROCEDURE. THE PATIENT WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 808:02. ACCORDING TO THE FACILITY, IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. DURING PRODUCT EVALUATION, THIS FAILURE CODE WAS CONFIRMED AND REPRODUCED WHEN IT INTERRUPTED DELIVERY DURING DEVICE TESTING. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.09.90.

    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