BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMA CONTROL UNIT

    MDR report key: 1122357 · Received August 18, 2008

    Report

    Report Number
    9616240-2008-00040
    Event Type
    Malfunction
    Date Received
    August 18, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 11, 2008
    Manufacturer
    GAMBRO DASCO
    Product Code
    KDI
    PMA / PMN Number
    K062090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO OTHER INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER. THE PRISMA OPERATOR'S MANUAL INFORMS ABOUT THE POSSIBLE INTERACTION BETWEEN AN ELECTRICALLY ISOLATED PERISTALTIC PUMP AND SOME EKG MONITORS. THE PRISMA IS A BF TYPE AS PER EN 60601-1 STANDARD. THIS PHENOMENON IS KNOWN IN CLINICAL LITERATURE AND IS NOT A PECULIARITY OF OUR MACHINE. THE PRISMA OPERATOR'S MANUAL STATES THE FOLLOWING: "OCCASIONAL DISTURBANCES HAVE BEEN REPORTED IN ELECTROCARDIOGRAM (ECG) RECORDING DURING RENAL REPLACEMENT THERAPY WITH THE PRISMA SYSTEM. THESE DISTURBANCES CAN APPEAR AS ARTIFACTS ON THE ECG TRACE AND MAY BE MISINTERPRETED AS ABNORMAL RHYTHM, ATRIAL FLUTTER, ETC. THE ELECTROCARDIOGRAPH CAN DETECT AN ELECTRICAL INTERFERENCE CAUSED BY ROTATION OF THE PRISMA BLOOD PUMP IF ANY ELECTRODE HAS AN INADEQUATE CONTACT IMPEDANCE WITH THE SKIN. THIS KIND OF ARTIFACT DISAPPEARS WHEN THE PRISMA PUMPS STOP. TO MINIMIZE OR AVOID PRISMA INTERFERENCE WITH ECG RECORDING, IT IS RECOMMENDED TO FOLLOW THE ECG SUPPLIER'S INSTRUCTIONS FOR CHRONIC PATIENT MONITORING CAREFULLY REGARDING USE OF SPECIFIC ELECTRODES WITH LOW CONTACT IMPEDANCE, AND CORRECT APPLICATION OF THE ELECTRODES, INCLUDING APPROPRIATE PLACEMENT OF THE N ELECTRODE." A SPECIFIC WARNING IN THE PRISMA OPERATOR'S MANUAL, WARNS THE OPERATOR: "IF A CARDIAC DYSRHYTHMIA IS EXHIBITED, PRESS THE STOP SOFTKEY ON THE PRISMA SYSTEM AND REASSESS THE CARDIAC RHYTHM BEFORE TREATING THE PATIENT. TO SIGNIFICANTLY REDUCE THE LIKELIHOOD OF PRODUCING ARTIFACTS, FOLLOW THE INSTRUCTIONS GIVEN IN APPENDIX D OF THIS MANUAL."

    Description of Event or Problem · 1

    GAMBRO RECEIVED A REPORT FROM A CUSTOMER WHO COMPLAINED OF EKG ARTIFACTS DURING EVERY PATIENT'S TREATMENT ON A PRISMA MACHINE. ALL EKG LINES ARE FLICKERING AND IT IS NOT POSSIBLE TO CHECK THE EKG DURING TREATMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AS A CONSEQUENCE OF THESE EVENTS. A GAMBRO TECHNICIAN INSPECTED THIS PRISMA MACHINE AND NO PROBLEM WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMA CONTROL UNIT INTENSIVE CARE HEMODIALYSIS KDI GAMBRO DASCO PRISMA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other