BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIFILTRATE PRO MACHINE

    MDR report key: 17732603 · Received September 12, 2023

    Report

    Report Number
    0001225714-2023-00072
    Event Type
    Malfunction
    Date Received
    September 12, 2023
    Date of Event
    August 30, 2023
    Report Date
    October 2, 2023
    Manufacturer
    SCHWEINFURT
    Product Code
    KDI
    PMA / PMN Number
    EUA200149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE REVIEW OF THE COMPLAINTS REVEALED THAT THE REPORTED FAILURE TYPE REPRESENTS A KNOWN EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) IS FOUND TO BE NOT NECESSARY DUE TO THE FACT THAT THE FAILURE/COMPLAINT CAN BE CLEARLY ATTRIBUTED TO THE FAILURE MODE DESIGN. AS THE REPORTED ERROR CODE IS A SPORADIC SOFTWARE PROBLEM, THERE IS NO RELATION TO REPAIR ACTIVITY. BASED ON ALL PERFORMED INVESTIGATIONS/EVALUATIONS THE DESCRIBED BEHAVIOR COULD BE REPRODUCED. THE REPORTED ERROR CODE IS A COLLECTIVE ERROR CODE FOR ALL KINDS OF PGM (POISSON, GAUSSIAN, AND MULTIPLICATIVE MISCALCULATION. THERE ARE MANY SOURCES OF PGM ERROR. PGM ERRORS RESULT IN THE DESCRIBED ERROR ON THE DIALYSIS MACHINE. AS THIS TYPE OF PGM ERROR CAN BE CAUSED BY DIFFERENT CAUSES, THERE IS CURRENTLY NOT A SINGLE ROOT CAUSE. THIS ERROR USUALLY LEADS TO THE TERMINATION OF THE TREATMENT AND TO THE STOP OF THE MACHINE. AFTER RESTARTING THE DEVICE, THE TREATMENT COULD BE CONTINUED. MANUAL BLOOD REINFUSION SHOULD ALWAYS BE POSSIBLE AND IS DESCRIBED IN INSTRUCTIONS FOR USE (IFU). THE REPORTED ERROR IS CONSIDERED WITHIN THE SCOPE OF THE PRODUCT IMPROVEMENT. NO HARDWARE COMPONENT IS ASSOCIATED WITH THIS COMPLAINT THEREFORE, NO HARDWARE / SAMPLE INVESTIGATION WAS PERFORMED. THERE ARE NO INDICATIONS ON THE BASIS OF RECEIVED COMPLAINT INFORMATION AND ALL INVESTIGATIONS THAT THE PRODUCT DEFICIENCY IS RELATED TO FALSIFICATION OR AN UNAUTHORIZED CONFIGURATION. THE RESIDUAL RISK IS BROADLY ACCEPTABLE.

    Additional Manufacturer Narrative · 0

    THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MULTIFILTRATE PRO MACHINE DISPLAYED 9046.1 ERROR THREE HOURS INTO A PATIENT¿S CONTINUOUS VENO-VENOUS HEMODIALYSIS (CVVHD). THE MACHINE WAS SHUT DOWN WITHOUT BLOOD RETURNED AND TREATMENT CONTINUED WITH ANOTHER MACHINE. THE PATIENT¿S BLOOD WAS NOT RETURNED, AND AS A RESULT THEY EXPERIENCED APPROXIMATELY 500 ML OF BLOOD LOSS. THE PATIENT REQUIRED TWO ERYTHROCYTE CONCENTRATES AS SUBSTITUTION. A SYSTEM CHANGE HAD ALREADY TAKEN PLACE DUE TO CLOTTING OF THE SYSTEM (CAPILLARIES WERE CLOGGED). THE TWO-TIME DISCARDING OF BLOOD-FILLED TUBING SYSTEMS RESULTED IN THE NEED FOR SUBSTITUTION AND CATECHOLAMINES. OVER TIME, THE PATIENT STABILIZED BACK TO THE INITIAL CIRCULATORY LEVEL. UPON FOLLOW UP, IT WAS CONFIRMED THAT THE PATIENT¿S TREATMENT WAS RESTARTED ON A NEW MACHINE, HOWEVER IT IS UNKNOWN IF TREATMENT WAS COMPLETED. THE REPORTED EVENT WAS DUE TO A SOFTWARE FAILURE. THERE WERE NO REPAIRS MADE TO THE MACHINE AS THE MACHINE PASSED A T1 TEST AND IS FULLY OPERATIONAL. THE SAMPLE WAS REPORTED TO NOT BE AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MULTIFILTRATE PRO MACHINE DISPLAYED 9046.1 ERROR THREE HOURS INTO A PATIENT¿S CONTINUOUS VENO-VENOUS HEMODIALYSIS (CVVHD). THE MACHINE WAS SHUT DOWN WITHOUT BLOOD RETURNED AND TREATMENT CONTINUED WITH ANOTHER MACHINE. THE PATIENT¿S BLOOD WAS NOT RETURNED, AND AS A RESULT THEY EXPERIENCED APPROXIMATELY 500 ML OF BLOOD LOSS. THE PATIENT REQUIRED TWO ERYTHROCYTE CONCENTRATES AS SUBSTITUTION. A SYSTEM CHANGE HAD ALREADY TAKEN PLACE DUE TO CLOTTING OF THE SYSTEM (CAPILLARIES WERE CLOGGED). THE TWO-TIME DISCARDING OF BLOOD-FILLED TUBING SYSTEMS RESULTED IN THE NEED FOR SUBSTITUTION AND CATECHOLAMINES. OVER TIME, THE PATIENT STABILIZED BACK TO THE INITIAL CIRCULATORY LEVEL. UPON FOLLOW UP, IT WAS CONFIRMED THAT THE PATIENT¿S TREATMENT WAS RESTARTED ON A NEW MACHINE, HOWEVER IT IS UNKNOWN IF TREATMENT WAS COMPLETED. THE REPORTED EVENT WAS DUE TO A SOFTWARE FAILURE. THERE WERE NO REPAIRS MADE TO THE MACHINE AS THE MACHINE PASSED A T1 TEST AND IS FULLY OPERATIONAL. THE SAMPLE WAS REPORTED TO NOT BE AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633951 MULTIFILTRATE PRO MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI SCHWEINFURT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown FRESENIUS TUBING KIT| FRESENIUS TUBING KIT