BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CXE VOLUMETRIC INFUSION PUMP SINGLE CHANNEL RECERT

    MDR report key: 1834336 · Received September 14, 2010

    Report

    Report Number
    6000001-2010-03221
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    June 17, 2010
    Report Date
    August 16, 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
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE WAS NOT PERVIOUSLY SERVICED FOR THE REPORTED CONDITION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECIEVED FOR THE REPORTED CONDITION. 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). DEVICE EVALUATION: THE REPORTED CONDITION WAS CONFIRMED BUT NOT DUPLICATED. THE ASSIGNABLE CAUSE WAS THAT THE AIL PCB (AR IN LINE PRINTED CIRCUIT BOARD) WAS OUT OF CALIBRATION. THE AIL PCB HAS BEEN RECALIBRATED.

    Description of Event or Problem · 1

    BASED ON BAXTER'S REVIEW OF THE DEVICE EVENT HISTORY, IT WAS DISCOVERED THAT FAILURE CODE 810:11 OCCURRED ONCE DURING INFUSION ON (B)(6) 2010 CAUSING AN INTERRUPTION OF DELIVERY. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION FOR THIS DEVICE IS 6.13.90, CATEGORIZED AS REMEDIATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD AN INCREASE IN RIGHT ATRIAL (RA) PACING THRESHOLDS MEASUREMENTS. FLUOROSCOPY INDICATED THE RA LEAD HAD PULLED BACK. THE LEAD ATTEMPTED TO BE EXTRACTED, BUT WAS FIBROSED TO THE DISTAL COIL OF THE PATIENT'S RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD. THE RV LEAD HAD PULLED BACK AND WAS PARTIALLY IN THE TRICUSPID VALVE. THE RA AND RV LEAD WERE SUCCESSFULLY EXTRACTED. A NEW RV LEAD WAS SUCCESSFULLY PLACED. THE RA LEAD WAS IMPLANTED AND DURING TESTING, IT WAS NOTICED THAT THE RV LEAD HAD AN ADDITIONAL AMOUNT OF SLACK IN IT. FLUOROSCOPY WAS TURNED ON AND THE RV LEAD JUMPED FORWARD AND WAS AT THE EDGE OF THE CARDIAC SILHOUETTE. THERE WAS SPECULATION THAT THE LEAD MAY HAVE PERFORATED. SIMULTANEOUSLY THE PATIENT'S BLOOD PRESSURE INCREASED AND THE EKG RHYTHM CHANGED. THE HELIX WAS RETRACTED AND THE LEAD WAS REPOSITIONED. THE PATIENT WENT INTO CARDIAC TAMPONADE AND A CODE WAS CALLED. THE PATIENT SUBSEQUENTLY HAD AN IMPELLA PUMP AND A BALLOON PUMP IMPLANTED. ONE DAY LATER TACHYCARDIA THERAPY WAS TURNED OFF AND THE PHYSICIAN ORDERED A DO NOT RESUSCITATE (DNR). THE PATIENT LATER DIED AND BRADY THERAPY WAS TURNED OFF POST- DEATH. THE DEVICE PLANNED TO BE BURIED WITH THE PATIENT.

    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