BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIFILTRATE PRO MACHINE

    MDR report key: 17247298 · Received July 3, 2023

    Report

    Report Number
    0001225714-2023-00049
    Event Type
    Malfunction
    Date Received
    July 3, 2023
    Date of Event
    June 13, 2023
    Report Date
    August 25, 2023
    Manufacturer
    SCHWEINFURT
    Product Code
    KDI
    PMA / PMN Number
    EUA200149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN A1, A3, A4, B5, AND D10.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE REVIEW OF SIMILAR COMPLAINTS REVEALED THAT THE REPORTED FAILURE TYPE REPRESENTS A KNOWN EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS NOT NECESSARY AS THE FAILURE/COMPLAINT CAN BE CLEARLY ATTRIBUTED TO THE FAILURE MODE DESIGN. BASED ON ALL PERFORMED INVESTIGATION AND EVALUATIONS THE DESCRIBED BEHAVIOR COULD BE REPRODUCED. THE 9040.1 ERROR IS A COLLECTIVE ERROR CODE FOR ALL KINDS OF PGM (POISSON, GAUSSIAN, AND MULTIPLICATIVE) MISCALCULATION. THERE ARE MANY SOURCES OF THE PGM ERROR. THE PGM ERROR RESULTED IN THE 9040.1 ERROR ON THE DIALYSIS MACHINE. AS THIS TYPE OF PGM ERROR CAN BE CAUSED BY DIFFERENT CAUSES, THERE IS NOT A SINGLE ROOT CAUSE. A 9040.1 ERROR USUALLY LEADS TO THE TERMINATION OF TREATMENT AND THE MACHINE TO STOP. AFTER RESTARTING THE DEVICE, THE TREATMENT COULD BE CONTINUED AND MANUAL BLOOD REINFUSION SHOULD BE POSSIBLE. THE 9040.1 ERROR IS CONSIDERED WITHIN THE SCOPE OF THE PRODUCT IMPROVEMENT. NO HARDWARE COMPONENT IS ASSOCIATED WITH THIS EVENT. 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

    ADDITIONAL INFORMATION RECEIVED STATES THAT SYSTEM ERROR CODE SYSTEM ERROR BATTERY, NOTIFY THE TECHNICAL SERVICE (9009.7) AS WELL AS A BLOOD LEAK ALARM. THE SYSTEM ERRORS OCCURRED 8.5 HOURS INTO TREATMENT (START (B)(6), 23 AT 07:30, MESSAGE AT (B)(6), 23 OM 16:00). TROUBLESHOOTING STEPS WERE NOT TAKEN AS THEY WERE NOT POSSIBLE DUE TO THE SYSTEM MESSAGE, BLOOD PUMP STOPPED, AND SYSTEM WAS ALREADY DARKENED AND CLOTTED. THE SYSTEM WAS SHUT DOWN AND A NEW SYSTEM WAS USED TO COMPLETE TREATMENT. NO REPAIRS HAVE BEEN MADE TO THE MACHINE, BUT IT HAS BEEN EXTENSIVELY CHECKED, TESTED, AND HAS BEEN RELEASED FOR USE. THERE WAS NO POSSIBILITY TO RETURN BLOOD, SO ABOUT 200 ML OF BLOOD WAS LOST. FURTHERMORE, THE PATIENT WAS NOT HARMED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED STATES THAT SYSTEM ERROR CODE SYSTEM ERROR BATTERY, NOTIFY THE TECHNICAL SERVICE (9009.7) AS WELL AS A BLOOD LEAK ALARM. THE SYSTEM ERRORS OCCURRED 8.5 HOURS INTO TREATMENT (START (B)(6) 23 AT 07:30, MESSAGE AT (B)(6) 23 OM 16:00). TROUBLESHOOTING STEPS WERE NOT TAKEN AS THEY WERE NOT POSSIBLE DUE TO THE SYSTEM MESSAGE, BLOOD PUMP STOPPED, AND SYSTEM WAS ALREADY DARKENED AND CLOTTED. THE SYSTEM WAS SHUT DOWN AND A NEW SYSTEM WAS USED TO COMPLETE TREATMENT. NO REPAIRS HAVE BEEN MADE TO THE MACHINE, BUT IT HAS BEEN EXTENSIVELY CHECKED, TESTED, AND HAS BEEN RELEASED FOR USE. THERE WAS NO POSSIBILITY TO RETURN BLOOD, SO ABOUT 200 ML OF BLOOD WAS LOST. FURTHERMORE, THE PATIENT WAS NOT HARMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MULTIFILTRATE PRO MACHINE HAD A SYSTEM ERROR 9040.1, AIR DETECTION ALARM, AFTER THE VENOUS AIR CATCHER AND IMMEDIATELY AFTER AN ALARM OF TOO HIGH PRESSURES DURING A PATIENT¿S CONTINUOUS VENO-VENOUS HEMODIALYSIS (CVVHD). EVENT OCCURRED SHORTLY (APPROXIMATELY 5 SECONDS) AFTER DISMOUNTING BUT ALSO DURING DISMOUNTING. THE PATIENT¿S BLOOD WAS NOT RETURNED, AND AS A RESULT THEY EXPERIENCED APPROXIMATELY 200 ML OF BLOOD LOSS. A NEW MACHINE WAS USED FOR TREATMENT. NO MEDICAL INTERVENTION REPORTED. THE SAMPLE WAS REPORTED TO NOT BE AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION REQUESTED BUT HAS NOT BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20806 MULTIFILTRATE PRO MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI SCHWEINFURT

    Patients

    Seq Age Sex Outcome Treatment
    1 Male CADDERA CALCIUMCHLORIDE SECUNECT 100MMOL/L| CADDERA CALCIUMCHLORIDE SECUNECT 100MMOL/L| CITRAAT 4% NA3 1500 ML SECUNECT| CITRAAT 4% NA3 1500 ML SECUNECT| DIALYSATE K4 PLUS| DIALYSATE K4 PLUS| MULTIFILTRATE PRO SECUKIT HD 1000| MULTIFILTRATE PRO SECUKIT HD 1000