BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBE CENTRYSYSTEM 3

    MDR report key: 139187 · Received December 20, 1997

    Report

    Report Number
    1713683-1997-00384
    Event Type
    Malfunction
    Date Received
    December 20, 1997
    Date of Event
    December 1, 1997
    Report Date
    December 4, 1997
    Manufacturer
    GAMBRO HEALTHCARE
    Product Code
    FII
    Removal / Correction Number
    Z-201-7
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE ALL RELATED FAILURE MODES DESCRIBED IN THE COMPLAINT HISTORY, DTF HISTORY, OR COMPONENT/ASSEMBLY LOT DTF HISTORY (WHERE APPLICABLE): A REVIEW OF CPF HISTORY SHOWED ONE PREVIOUS COMPLAINT REGARDING UF PUMP. UF PUMP THERMAL FUSE FAILED DURING TREATMENT. THIS IS NOT RELATED TO THIS COMPLAINT WHERE EXTERNAL WIRE TO FUSE WAS BROKEN, BECAUSE REVIEW OF COMPLAINT #0996029C3 WAS DUE TO OPEN (FAILED) THERMAL FUSE. SECONDARY SEARCH OF DTF HISTORY IS NOT POSSIBLE WITHOUT LOT NUMBER. IDENTIFICATION OF PRODUCTION EQUIPMENT DMM HK14077. TEST PROCEDURE FOLLOWED: QARA-146 SECT. 9.0. REVISION: 1. TEST RESULTS/ANALYSIS AND ANY DATA RECORDED: PUMP WAS DISASSEMBLED AND IT WAS NOTED THAT PLUNGER WAS CORRODED, THUS, CAUSING PLUNGER TO SEIZE. MFG ENGINEERING WAS CONTACTED ON THIS ISSUE, AND STATED THAT THIS HAS BEEN SEEN BEFORE, BUT IT IS UNKNOWN WHY CORROSION OCCURS. THEREFORE, REPORTED CONDITION COULD HAVE BEEN CAUSED BY EITHER INTERMITTENT FUSE, OR CORRODED PLUNGER CAUSING PUMP TO OVERHEAT AND EVENTUALLY SEIZE, OR BOTH. SAFTEY ANALYSIS: IT IS RECOMMENDED THAT: 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 THE 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. FOLLOWUP ACTION: REPORTED COMPLAINT CONDITION WAS TRACED TO PARTIALLY BROKEN CONNECTION ON UF PUMP THERMAL FUSE CAUSING FUSE TO BECOME INTERMITTENT. ADDITONALLY, CORROSION WAS ALSO FOUND ON PLUNGER CAUSING PUMP TO OVERHEAT, AND EVENTUALLY SEIZE. THIS REPORT MUST REMAIN INCONCLUSIVE AS TO CAUSE OF INCIDENT IN THIS REPORT. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF GAMBRO HEALTHCARE CORRECTIVE ACTION SYSTEM AND MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATION, 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

    INSUFFICIENT WEIGHT REMOVAL DUE TO FAILURE OF UF PUMP. CUSTOMER REPORTS THAT THE PUMP PISTON IS NOT MOVING FREELY, OVERHEATING THE PUMP. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.

    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 Other