BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBE CENTRYSYSTEM 3

    MDR report key: 139183 · Received December 20, 1997

    Report

    Report Number
    1713683-1997-00386
    Event Type
    Malfunction
    Date Received
    December 20, 1997
    Report Date
    November 20, 1997
    Manufacturer
    GAMBRO HEALTHCARE
    Product Code
    FII
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CENTRYSYSTEM 3 WAS BEING USED FOR PT TREATMENT AT TIME OF INCIDENT. GAMBRO TECH SERVICES (GTS) REP DID NOT IDENTIFY THIS EVENT AS MDR-REPORTABLE AT TIME OF MACHINE REPAIR. IT WAS NOT UNTIL ROUTINE AUDIT WAS CONDUCTED BY QA THAT AN MDR-REPORTABLE EVENT WAS IDENTIFIED. THUS, NO PRODUCT WAS RETURNED FOR INVESTIGATION. GTS REP THAT REPAIRED MACHINE DID, HOWEVER, DIAGNOSE AND DOCUMENT FAILURE MODE IN FIELD. TRACEABILITY AND COMPLAINT/DTF HISTORIES: GAMBRO HEALTH TRACE NUMBER OF RETURNED COMPONENT/ASSEMBLY (WHEN APPLICABLE): N/A DESCRIBE ALL RELATED FAILURE MODES DESCRIBED IN COMPLAINT HISTORY, DTF HISTORY, OR COMPONENT/ASSEMBLY LOT DTF HISTORY (WHEN APPLICABLE): REVIEW OF DTF HISTORY DOES NOT INDICATE THAT THIS OR RELATED CONDITION WAS PRESENT AT TIME OF MFR. REVIEW OF CPF HISTORY FOR SPECIFIC SERIAL NUMBER MACHINE WAS RELEASED TO FIELD. SECONDARY SEARCH OF DTF HISTORY FOR THIS PRODUCTION LOT IS NOT POSSIBLE SINCE COMPONENT WAS NOT RETURNED FOR INVESTIGATION. TEST PROCEDURE FOLLOWED: QARA-146 SECT. 2.3 REVISION: 1 MFG SPECIFICATIONS TESTED TO (IF CLEARLY ESTABLISHED IN TEST PROCEDURE): N/A TEST RESULTS/ANALYSIS AND ANY DATA RECORDED: TECH AT FACILITY REPLACED UF PUMP THERMAL FUSE. PUMP WAS NOT RETURNED FOR INVESTIGATION. THIS WAS ORIGINAL THERMAL FUSE INSTALLED AT TIME OF MFR FOR THIS MACHINE. MES TECH REPLACED UF PUMP AS PRECAUTION. UF PUMP WAS NOT RETURNED FOR INVESTIGATION. SINCE NO PART WAS RETURNED FOR INVESTIGATION, NO INVESTIGATION CAN TAKE PLACE. IT HAS BEEN SEEN PREVIOUSLY THAT WAX INSIDE THERMAL FUSE MELTS, CAUSING FUSE TO OPEN. THIS IS WHAT FUSE IS SUPPOSED TO DO, TO PROTECT UF PUMP FROM OVER-HEATING. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT WAX MELTS AT CORRECT TEMPERATURE. IT IS UNKNOWN WHY THERMAL FUSE IN THIS INCIDENT FAILED. SAFETY ANALYSIS: TO HELP DETECT ULTRAFILTRATION PUMP FAILURES AND TO VERIFY ULTRAFILTRATION SYSTEM INTEGRITY, IT IS RECOMMENDED IN CENTRYSYSTEM 3 OPERATOR'S MANUAL THAT AUTOTEST BE PERFORMED: PRIOR TO FIRST TREATMENT OF DAY, IF MACHINE HAS BEEN TURNED OFF, IF PT WEIGHT DISCREPANCY IS DISCOVERED, OR AFTER ANY CLEAN, DISINFECT, ACID RINSE, OR RINSE FUNCTION (P. 3-19, VERSION 1995/10). OPERATOR IS ALSO INSTRUCTED TO PERFORM A KUF COMPARISON OF CALCULATED VALUE TO ACTUAL VALUE AFTER TREATMENT BEGINS. THIS VERIFIES THAT ULTRAFILTRATION RATE IS AS EXPECTED. FOLLOW-UP ACTION: COMPONENT WAS NOT RETURNED FOR INVESTIGATION. BASED ON SERIAL NUMBER OF MACHINE, THIS IS POST-FAR THERMAL FUSE. THIS REPORT MUST REMAIN INCONCLUSIVE AS TO CAUSE OF INCIDENT IN THIS REPORT. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF GAMBRO HEALTH CORRECTIVE ACTION SYSTEM AND MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS.

    Description of Event or Problem · 1

    POSSIBLE INACCURATE WEIGHT REMOVAL. GAMBRO TECHNICAL SERVICES REP FOUND BROKEN JUMPER WIRE ON THE ULTRAFILTRATION (UF) PUMP THERMAL FUSE.

    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 NA Other