BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMA CONTROL UNIT

    MDR report key: 1021894 · Received March 31, 2008

    Report

    Report Number
    9616240-2008-00021
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 21, 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. IN FACT, OUR DEVICE PRISMA IS A BF TYPE AS PER STANDARD. THESE PHENOMENA ARE KNOWN IN CLINICAL LITERATURE AND ARE NOT A PECULIARITY OF OUR MACHINE. IT MUST BE REMARKED THAT GOOD CLINICAL PRACTICES, SUCH AS: CORRECT EKG ELECTRODES POSITIONING ON THE PATIENT; ADEQUATE SKIN/ELECTRODES CONTACT TO MINIMIZE ELECTRICAL IMPEDANCE; GOOD QUALITY EKG LEAD WIRES AND ELECTRODES; AND FINALLY ADEQUATE EKG MONITOR SHIELDING IMPLEMENTED BY THE EKG MANUFACTURER ARE FUNDAMENTAL ELEMENT IN MINIMIZING EKG ARTIFACTS IN A INTENSIVE CARE UNIT ENVIRONMENT. BEING EKG ARTIFACTS THE RESULT OF DIFFERENT FACTORS, IT IS, THEREFORE, IMPORTANT FOLLOWING THE INDICATIONS INCLUDED IN THE PRISMA OPERATOR'S MANUAL ADDENDUM: NOTE ON THE COMBINED USE OF PRISMA AND THE ECG MONITORING SYSTEM: "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 (1) USE OF SPECIFIC ELECTRODES WITH LOW CONTACT IMPEDANCE, AND (2) CORRECT APPLICATION OF THE ELECTRODES, INCLUDING APPROPRIATE PLACEMENT OF THE N ELECTRODE." MOREOVER, SPECIFIC WARNINGS ON 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 B/D OF THIS MANUAL." GAMBRO DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OF RESPONSIBILITY FOR THE EVENT. THIS EVENT IS BEING REPORTED AS "MALFUNCTION" UNDER THE MDR 2-YEAR RULE, REGARDLESS OF ANY PATIENT INJURY.

    Description of Event or Problem · 1

    GAMBRO RECEIVED A REPORT FROM A CUSTOMER WHO COMPLAINED OF ECG ARTIFACTS DURING A PATIENT'S TREATMENT ON A PRISMA MACHINE. NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AS A CONSEQUENCE OF THIS EVENT. A GAMBRO TECHNICIAN INSPECTED THE MACHINE AND FOUND IT WORKING WITHIN MANUFACTURER'S SPECIFICATIONS.

    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