BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE CENTRYSYSTEM 3

    MDR report key: 71439 · Received February 27, 1997

    Report

    Report Number
    1713683-1997-00168
    Event Type
    Injury
    Date Received
    February 27, 1997
    Date of Event
    January 29, 1997
    Report Date
    January 31, 1997
    Manufacturer
    GAMBRO HEALTHCARE
    Product Code
    FII
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    GAMBRO HEALTHCARE ATTEMPTED TO RETURN AFFECTED VALVES TO VENDOR FOR ANALYSIS AND BECAUSE OF THIS, VALVES WERE NOT DISASSEMBLED AT GAMBRO HEALTHCARE FOR FAILURE INVESTIGATION. VENDOR, HOWEVER, REFUSED VALVES AND VALVES WERE DISASSEMBLED AND EVALUATED AT GAMBRO HEALTHCARE. FACILITY ADMINISTERED 650 CC OF SALINE, ALONG WITH 4 DOSES OF HYPERTONIC SALINE. PT WAS KEPT FOR OBSERVATION AND IS CURRENTLY REPORTED TO BE OKAY. A MES (MEDICAL EQUIPMENT SERVICE) TECH EXAMINED AND REPLACED BALANCE CHAMBER VALVES AND DUMP VALVE. A REVIEW OF DTF HISTORY DOES NOT APPLY. A REVIEW OF CPF HISTORY FOR SPECIFIC SERIAL NUMBER MACHINE DOES NOT INDICATE THAT THIS HAS BEEN A RECCURING CONDITION SINCE THIS MACHINE WAS RELEASED TO FIELD. A SECONDARY SEARCH OF DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. IDENTIFICATION OF PRODUCTION EQUIPMENT (N/A IF NOT USED): DMM HJ4399. PRESSURE METER HK 15404. TEST PROCEDURE FOLLOWED: QARA-146 SECT. 9.0, REVISION: H. MES TECH REPLACED BALANCE CHAMBER VALVES AND DUMP VALVE. BALANCE CHAMBERS WERE RETURNED TO MFR ON 3/11/97 FOR INVESTIGATION. RETURNED BALANCE CHAMBERS VALVES WERE VISUALLY EXAMINED. ALL OF VALVES WERE CHECKED WITH AN OHM METER AND WERE OKAY. VENDOR SPECIFICATION FOR SOLENOID IS 60 OHMS +/- 1.5 OHMS AT 20 DEGREES C. ALL OF VALVES WERE WITHIN SPECIFICATION. DUMP VALVE WAS TESTED SEPARATELY, SINCE IT IS A NORMALLY OPEN VALVE, AND WAS FOUND TO BE OPERATING CORRECTLY. BALANCE CHAMBER VALVES WERE PRESSURIZED TO 1200 MMHG. USING A SYRINGE AND A PRESSURE METER. TWO VALVES LEAKED AND COULD NOT BE PRESSURIZED TO MORE THAN 100 MMHG. A LEAKING BALANCE CHAMBER VALVE COULD LEAD TO UNCONTROLLED WEIGHT REMOVAL, DEPENDING ON LOCATION OF VALVE ON BALANCE CHAMBER. SINCE BALANCE CHAMBER VALVES WERE RETURNED IN A BAG, UNNUMBERED, IT IS UNK FOR CERTAIN WHICH POSITION THIS VALVE IS FROM. SINCE COMPLAINT CONDITION IS CONSISTENT WITH EXCESS WEIGHT REMOVAL AND IDENTIFIED VALVE FAILURE COULD CAUSE EXCESS WEIGHT REMOVAL, IT WILL BE ASSUMED THAT THIS IS CAUSE OF INCIDENT. FAILED VALVES WOULD NORMALLY BE RETURNED TO VENDOR FOR FURTHER ANALYSIS. VENDOR HAS PREVIOUSLY STATED THAT VALVES RETURNED FOR INVESTIGATION SHOULD NOT BE DISASSEMBLED PRIOR TO SHIPMENT TO VENDOR FOR ANALYSIS. HOWEVER, SINCE VENDOR WOULD NOT RECEIVE VALVES FOR INVESTIGATION, FURTHER INVESTIGATION WAS PERFORMED BY MFR. VALVES WERE INSTALLED INTO LAB MACHINE AND AUTOTEST WAS PERFORMED. MACHINE FAILED AFTER 4 MINUTES AND ULTRAFILTRATION TEST FAILED WAS DISPLAYED ON SCREEN. VALVES WERE DISASSEMBLED AND IT WAS SEEN THAT THERE WAS PRECIPITATE ON RIM OF HOUSING, WHERE PLUNGER SEATS TO SEAL VALVE. CAUSE OF LEAKAGE WAS PRECIPITATE, WHICH PREVENTED PLUNGER FROM SEATING FULLY. INCIDENT IN THIS REPORT WAS CAUSED BY LEAKING BALANCE CHAMBE VALVES. PRECIPITATE INSIDE VALVE HOUSING CAUSED PLUNGER NOT TO SEAT, CAUSING LEAK. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF GAMBRO HEALTHCARE CORRECTIVE ACTION SYSTEM AND MANAGEMENT REVIEW TEAM.

    Description of Event or Problem · 1

    THERE WAS EXCESS WEIGHT REMOVAL AFTER A DIALYSIS TREATMENT. THE PT BECAME HYPOTENSIVE, THE BLOOD PRESSURE DROPPED AND SALINE WAS ADMINISTERD.

    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