BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIFILTRATE PRO MACHINE

    MDR report key: 17599246 · Received August 22, 2023

    Report

    Report Number
    0001225714-2023-00066
    Event Type
    Malfunction
    Date Received
    August 22, 2023
    Date of Event
    August 8, 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
    NURSE
    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. THE SYSTEM BEHAVED ACCORDING TO ITS SPECIFICATIONS.

    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 HAD A SUDDEN SYSTEM ERROR 9040 DURING A PATIENT¿S CONTINUOUS VENO-VENOUS HEMODIALYSIS (CVVHD). TREATMENT WAS DISCONTINUED. THE PATIENT¿S BLOOD WAS NOT RETURNED, AND AS A RESULT THEY EXPERIENCED APPROXIMATELY 500 ML OF BLOOD LOSS WITH VOLUME SUBSTITUTION. THE PATIENT¿S TREATMENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY. THERE WERE NO REPAIRS PERFORMED AND THE MACHINE 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 HAD A SUDDEN SYSTEM ERROR 9040 DURING A PATIENT¿S CONTINUOUS VENO-VENOUS HEMODIALYSIS (CVVHD). TREATMENT WAS DISCONTINUED. THE PATIENT¿S BLOOD WAS NOT RETURNED, AND AS A RESULT THEY EXPERIENCED APPROXIMATELY 500 ML OF BLOOD LOSS WITH VOLUME SUBSTITUTION. THE PATIENT¿S TREATMENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY. THERE WERE NO REPAIRS PERFORMED AND THE MACHINE IS FULLY OPERATIONAL. THE SAMPLE WAS REPORTED TO NOT BE AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53728 MULTIFILTRATE PRO MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI SCHWEINFURT

    Patients

    Seq Age Sex Outcome Treatment
    1 Female FRESENIUS BLOODLINES| FRESENIUS BLOODLINES| FRESENIUS DIALYZER| FRESENIUS DIALYZER