BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBE CENTRYSYSTEM 3

    MDR report key: 57527 · Received December 20, 1996

    Report

    Report Number
    1713683-1996-00242
    Event Type
    Malfunction
    Date Received
    December 20, 1996
    Date of Event
    December 6, 1996
    Report Date
    December 20, 1996
    Manufacturer
    GAMBRO HEALTHCARE
    Product Code
    FII
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED CS3 MACHNINE WAS THOROUGHLY CHECKED OUT BY A MEDICAL EQUIPMENT SVC TECH, (MES) AND NO DEFECTS WERE FOUND: PRESSURE ALARM LIMITS WERE WITHIN MFG SPECIFICATIONS. THEREFORE, NO PARTS WERE RETURNED RELATED TO PRESSURE MONITORING. RETURN OF BLOOD PUMP MOTOR IS NOT RELATED TO SITUATION WHICH GENERATED THIS MDR. BLOOD PUMP OPERATION IS NOT DIRECTLY RELATED TO ISSUE OF A PRESSURE ALARM WITH NEEDLE DISPLACEMENT. PUMP WAS REPLACED ONLY BACAUSE OF MOTOR NOISE. NONETHELESS, RETURNED BLOOD PUMP MOTOR WAS PLACED INTO A CALIBRATED CS3 MACHINE: IT OPERATD NORMALLY. MACHINE RAN FOR FOUR HOUR AND MOTOR DID NOT MAKE ANY LOUD AND/OR UNUSUAL NOISES. MOTOR WAS THEN PLACED ONTO PRODUCTION TESTER 850151-065 AND TESTED PER PROCEDURE 223047-003 STEPS 19-30 AND PASSED WITH NO DEFECTS. THUS, REPORTED CONDITION WAS NOT DUPLICATED. SAFETY ANALYSIS: PREVENTIVE MEASURE FOR THIS MDR ISSIE IS TO SECURELY FASTEN NEEDLE TO ARM OF PT BY TAPE OR OTHER MEASURES SO THAT RANDOM MOVEMENT BY PT DOES NOT DISLODGE NEEDLE. IN ADDITION, ALARM WINDOW CAN BE SET TIGHTER (AS SMALL AS 4 MMHG). ALSO, VENOUS PRESSURE LOW ALARM WINDOW IS TIGHTNED, POTENTIAL FOR NUISANCE PRESSURE ALARM WHICH INTERRUPT TREATMENT CORRESPONDINGLY INCREASES (SEE FAR# 960007). IF BLOOD PUMP MOTOR WAS TO GENERATE A SLIGHT NOISE THERE WOULD NOT BE ANY PT SAFETY ISSUES BECAUSE NOISE DOES NOT AFFECT OPERATION OF MACHINE OF TREATMENT. IF BLOOD PUMP WAS TO GENERATE A VERY LOUD AND DISTINGUISHABLE NOISE OVER A PERIOD OF TIME, MOTOR MAY BE AT RISK OF SEIXING. IF BLOOD WAS TO SIEZE CS3 MACHINE WOULD GENERATE A BLOOD PUMP OVER TORQUE ALARM. THIS ALARM CONSITS OF A VISUAL FLASHING RED LIGHT, AND A STEADY AUDIBLE ALARM. ALARM WOULD ALSO STOP BLOOD PUMP AND CLAMP VENOUS BLOOD LINE AS STATED IN CS3 OPERATOR'S MANUAL VERSION 1995/10, SECTION 5-37. ALARM ALSO REQUIRES A MANUAL RESET TO CONTINUE WITH TREATMENT, IF ALARM DOES NOT RESET OPERATOR MAY TERMINATE TREATMENT AND MANUALLY RETURN BLOOD. THUS, THERE ARE NO PT SAFETY ISSUES. FOLOW-UP ACTION: ABOVE INFO INDICATES THAT REPORTED CS3 MACINE MET MFG SPECIFICATIONS. SEE FAR #960007. ABOVE TESTING INDICATES THAT BLOOD PUMP MOTOR MET MFG SPECIFICATIONS.

    Description of Event or Problem · 1

    DURING A DIALYSIS TREATMENT, THE VENOUS NEEDLE DISLODGED FROM THE PT ACCESS SITE WITH NO MACHINE ALARM. BLOOD LOSS WAS ESTIMATED AT 2 UNITS.

    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