BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE CENTRYSYSTEM 3

    MDR report key: 39130 · Received September 23, 1996

    Report

    Report Number
    1713683-1996-00025
    Event Type
    Injury
    Date Received
    September 23, 1996
    Report Date
    September 23, 1996
    Manufacturer
    GAMBRO HEALTHCARE
    Product Code
    FII
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A DIALYSIS MACHINE REMOVED 2 KG TOO MUCH FLUID. SALINE WAS ADMINISTERED AS A MEDICAL. THE MEDICAL EQUIPMENT SERVICE TECH (MES) FOUND THAT THE PRV3 CRACK PRESSURE WAS AT 730 MMHG. HE RECALIBRATE PRV3 TO 1015 MMHG. THE PRESSURE SPECIFICATION FOR PRV3 IS : 930-1035 MMHG. THERE WERE NOT RELATED CPF DEFECTS REPORTED. NO PART WAS RETURNED FOR THIS SERVICE CALL SINCE THE PART WAS RECALIBRATED AND RE-INSTALLED. THE EXACT REASON FOR THE CRACK PRESSURE'S TO 730 MMHG IS NOT KNOWN. HOWEVER, THE CHANGE IN CRACK PRESSURE, PER THE FOLLOWING ANALYSIS, CLEARLY DOES NOT APPEAR TO BE CAUSED BY A GRADUAL DRIFT IN THE SETTING. IF PRV3 DRIFTS GROSSLY OUT OF SPECIFICATIONS (LOW TO ABOUT 500-700 MMHG), IT IS POSSIBLE THAT IT COULD OPEN AN ALLOW UNACCOUNTED-FOR FLUID REMOVAL FROM THE PT. HOWEVER, INAPPROPRIATE OPENING OF THE VALVE CAN BE DETECTED SINCE THE KUF OF THE DIALYZER WOULD BE INAPPROPRIATE (THE KUF SHOULD BE CHECKED PER THE OPERATOR'S HANDBOOK AT THE BEGINNING OF EACH DIALYSIS). AUTOTEST IS A SECOND SYSTEM TEST WHICH WOULD IDENTIFY THE INCORRECT PRV-3 SETTING. BOTH AUTOTEST AND THE KUF CHECK ARE DONE BEFORE THE PT GEST ON THE MACHINE. ADDITIONALLY, AS THE ATTACHED DATA INDICATE, PRV-3 DRIFT IS 13.4 MMHG 4.24 MMHG (1 STANDARD DEVIATION). THUS, THERE ARE OVER 5 STANDARD DEVIATIONS BETWEEN THE 700 MMGH VALUE AT WHICH A PRV-3 MAY STAR TO LEAK AND THE MINIMUN CALIBRATION SETTING FOR PRV-3 OF 930 MMHG. THEREFORE, THERE IS LESS THAN A REMOTE CHANCE THAT A PRV-3 WOULD "DRIFT" TO A LOW ENOUGH VALUE TO LEAK BETWEEN PM'S. IT IS MUCH MORE LIKELY THAT THE SETTING OF THE PRV CHANGED DUE TO AN UNIDENTIFIED EVENT RATHER THAN GRADUAL DRIFTING. THIS MDR RESPONSE WAS EXTENDED TO GATHER INFORMATION FROM THE FIELD REGARDING THE DEGREE OF PRV-3 DRIF BETWEEN CALIBRATION PERIOD. THE COMPLAINT FAILURE WAS TRACED TO AN CHANGED IN THE SETTING OF THE PRV DUE TO AN EVENT OF UNK ORIGIN. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATION, ANALYSIS, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. FAILURE CODES: F. CODE PRRVS097WL. CUSTOMER CONTACTED: N. SALES/SERVICE CONTACTED BY INVESTIGATOR? N. TRAINING REQUIRED? N.

    Description of Event or Problem · 1

    DURING A DIALYSIS TREATMENT, THERE WAS EXCESS WEIGHT REMOVAL. MEDICAL INTERVENTION WAS REQUIRED. PT'S BLOOD PRESSURE DROPPED AND PT LOST CONSCIOUSNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT FII GAMBRO HEALTHCARE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention