BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR

    MDR report key: 17591209 · Received August 21, 2023

    Report

    Report Number
    3004634229-2023-00001
    Event Type
    Death
    Date Received
    August 21, 2023
    Date of Event
    July 11, 2023
    Report Date
    September 19, 2024
    Manufacturer
    FRESENIUS HEMOCARE GMBH
    Product Code
    LKN
    PMA / PMN Number
    K060734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PER FRESENIUS KABI FRANCE, A REPORT WAS RECEIVED OF AN UNCONSCIOUS PATIENT ADMITTED FOR PLASMA EXCHANGE. THE TEAM MOUNTED A PL1 KIT (MATERIAL: 940401C, BATCH: MLT 161) ON THE COMTEC (MATERIAL: C9008021, SERIAL: (B)(6) AND PROCEEDED WITH THE PURGE. ALL WENT WELL. THE REGISTERED NURSE VALIDATED THE STEPS ON THE COMTEC UP TO THE PATIENT CONNECTION PHASE. THE REGISTERED NURSE CONNECTED THE INLET AND RETURN LINES TO THE PATIENT'S CATHETER AND SET UP THE SALINE DRIP. NORMALLY, THE PROCEDURE CAN THEN BE STARTED, BUT THE TEAM WAS WAITING FOR BAGS OF FRESH FROZEN PLASMA AS A SUBSTITUTE LIQUID TO START THE PROCEDURE. AFTER AN ESTIMATED 20 MINUTES, WITH THE PROCEDURE STILL TO BE STARTED, THE PATIENT BEGAN TO EXPERIENCE HEART PROBLEMS. THE TEAM ATTENDED TO THE PATIENT, INVESTIGATING THE POSSIBLE CAUSES OF THE MALAISE IN RELATION TO THE PATIENT'S PATHOLOGY AND THE MEDICATION ADMINISTERED. AFTER AN ESTIMATED 60 MINUTES, THE TEAM DISCONNECTED THE PATIENT, AT WHICH POINT THEY REALIZED THAT THE ACD BAG WAS COMPLETELY EMPTY. THE PATIENT DIED. NO ALARM WAS TRIGGERED ON THE DEVICE. A TEST WAS PERFORMED, AND THE DRIP WAS VERY WEAK. UPON EXAMINING THE UNIT, IT WAS NOTED THERE WAS A PROBLEM WITH THE PUMP HEAD OF THE ACD PUMP ON THE COMTEC DEVICE; A PLASTIC PART SEEMED TO BE BROKEN. THE DEVICE HAS BEEN TAKEN OUT OF SERVICE WHILE THIS EVENT IS UNDER INVESTIGATION. NOTE: THE COMTEC DEVICE MATERIAL: C9008021 IS NOT MARKETED IN THE US. HOWEVER, A SIMILAR DEVICE MATERIAL: 9008031 IS MARKETED IN THE US UNDER 510K K060734.

    Description of Event or Problem · 0

    INITIAL MDR INFORMATION: PER FRESENIUS KABI FRANCE, A REPORT WAS RECEIVED OF AN UNCONSCIOUS PATIENT ADMITTED FOR PLASMA EXCHANGE. THE TEAM MOUNTED A PL1 KIT (MATERIAL 940401C, BATCH MLT 161) ON THE COMTEC (MATERIAL C9008021, SERIAL (B)(6)) AND PROCEEDED WITH THE PURGE. ALL WENT WELL. THE REGISTERED NURSE VALIDATED THE STEPS ON THE COMTEC UP TO THE PATIENT CONNECTION PHASE. THE REGISTERED NURSE CONNECTED THE INLET AND RETURN LINES TO THE PATIENT'S CATHETER AND SET UP THE SALINE DRIP. NORMALLY, THE PROCEDURE CAN THEN BE STARTED, BUT THE TEAM WAS WAITING FOR BAGS OF FRESH FROZEN PLASMA AS A SUBSTITUTE LIQUID TO START THE PROCEDURE. AFTER AN ESTIMATED 20 MINUTES, WITH THE PROCEDURE STILL TO BE STARTED, THE PATIENT BEGAN TO EXPERIENCE HEART PROBLEMS. THE TEAM ATTENDED TO THE PATIENT, INVESTIGATING THE POSSIBLE CAUSES OF THE MALAISE IN RELATION TO THE PATIENT'S PATHOLOGY AND THE MEDICATION ADMINISTERED. AFTER AN ESTIMATED 60 MINUTES, THE TEAM DISCONNECTED THE PATIENT, AT WHICH POINT THEY REALIZED THAT THE ACD BAG WAS COMPLETELY EMPTY. THE PATIENT DIED. NO ALARM WAS TRIGGERED ON THE DEVICE. A TEST WAS PERFORMED, AND THE DRIP WAS VERY WEAK. UPON EXAMINING THE UNIT, IT WAS NOTED THERE WAS A PROBLEM WITH THE PUMP HEAD OF THE ACD PUMP ON THE COMTEC DEVICE; A PLASTIC PART SEEMED TO BE BROKEN. THE DEVICE HAS BEEN TAKEN OUT OF SERVICE WHILE THIS EVENT IS UNDER INVESTIGATION. NOTE: THE COMTEC DEVICE MATERIAL C9008021 IS NOT MARKETED IN THE US. HOWEVER, A SIMILAR DEVICE MATERIAL 9008031 IS MARKETED IN THE US UNDER 510K K060734. FOLLOW-UP MDR INFORMATION: INVESTIGATION: AN UNCONSCIOUS PATIENT WAS CONNECTED TO THE COM.TEC DEVICE, SET UP COMPLETELY WITH AN PL1 PLASMA EXCHANGE SET. THE PROCEDURE WAS NOT STARTED AS THE TEAM WAS WAITING FOR FFP SUBSTITUTE. AFTER 20 MINS, HEART PROBLEMS WERE OBSERVED AND AFTER 60 MINS THE PATIENT WAS DISCONNECTED FROM THE DEVICE. AN EMPTY BAG OF ACD WAS OBSERVED. THE CONDITION OF THE PATIENT WORSENED, LEADING TO THE DEATH OF THE PATIENT. THE DEVICE WAS TRANSFERRED TO FRIEDBERG FOR INVESTIGATION, AFTER THE DETAILS BETWEEN THE PARTIES INVOLVED COULD BE CLARIFIED. THE INVESTIGATION REVEALED THAT A DEFECT OCCURRED ON THE PUMP ROTOR, WHICH IS SQUEEZING THE PUMP TUBE SEGMENT OF THE KIT IN THE PUMP HOUSING ESTABLISHING THE PUMP OCCLUSION. THE HINGE OF THE PUMP ROTOR WAS FOUND BROKEN. THIS LED TO THE FUNCTION OF THE PUMP ROTOR BEING RESTRICTED AND DUE TO THE POSITION OF THE ROTOR IN THE PUMP HOUSING ENABLING THE ACD TO FLOW THROUGH THE DISPOSABLE. THIS WAS CONFIRMED DURING INVESTIGATION AT THE PRODUCTION UNIT. A COMPLAINT ANALYSIS WAS PERFORMED FOR THE LAST 15 YEARS (2008-2023) FOR THE COM.TEC DEVICE. NO SIMILAR COMPLAINTS FOR THE DEFECT OF THE PUMP ROTOR HINGE HAVE BEEN RECEIVED. THE PUMP ROTOR IN (B)(6) WAS THE FACTORY INSTALLED ONE FROM 2008. ROOT CAUSE: THE INVESTIGATION REVEALED THAT THE PATIENT DEATH OCCURRED BY THE COMBINATION OF SEVERAL CONTRIBUTING FACTORS: THE DEVICE WAS SET UP AND THE PATIENT WAS CONNECTED, BUT THE PROCEDURE WAS NOT STARTED WITHIN A USUAL TIME FRAME BY THE OPERATOR, LEADING TO THE DEVICE MONITORING OF THE ACD DROPS TO NOT BEEN ACTIVATED AT THE TIME. THE PATIENT WAS UNCONSCIOUS AND WAS NOT ABLE TO VERBALIZE POSSIBLE SYMPTOMS OF THE ACD OVERDOSE. A DEFECT WAS FOUND IN THE PUMP ROTOR COMPONENT OF THE DEVICE, WHICH RESULTED IN THE ACD BEING ABLE TO FLOW THROUGH THE DISPOSABLE SET TO THE PATIENT IN A CERTAIN POSITION OF THE ROTOR. CAPA: AS THIS IS AN ISOLATED CASE WITH MORE THAN 20 YEARS OF PRODUCT EXPERIENCE AND NOT A RECURRING OR GENERAL MALFUNCTION, A KABITRACK EVENT WAS OPENED INSTEAD OF A CAPA IN ORDER TO INVESTIGATE THIS INDIVIDUAL CASE FURTHER. RISK ASSESSMENT: THE ISSUE WAS CAUSED BY A MECHANICAL DEFECT ON THE PUMP ASSEMBLY FOR THE ACD DELIVERY. THE RISK ANALYSIS WAS CHECKED. THE BEST CORRESPONDING RISK IS DEFINED AS FOLLOWS: THE "ACD PUMP / RECIRCULATION PUMP (YELLOW/GREEN") SHOWS AN "INCORRECT OR INAPPROPRIATE OUTPUT OR FUNCTIONALITY" (HAZARD) LEADING TO "INSUFFICIENT OR NO BLOOD PROCESSING" (FORESEEABLE SEQ. OF EV.) RESULTING IN "DELAYED MEDICAL TREATMENT: DIRECTED BLOOD PRODUCT NOT ACC. TO SPEC/ INSUFFICIENT PATIENT CARE: IMPAIRED DIRECTED TRANSFUSION PRODUCT" (HARM). THE REPORTED FORESEEABLE SEQUENCE OF EVENTS, HARM AND THE IDENTIFIED ROOT CAUSE WITHIN THE COMPLAINT IS NOT COVERED IN THE CURRENT RISK ANALYSIS. THE OCCURRED HARM AS RESULT OF THE MECHANICAL DEFECT OF THE PUMP ROTOR WILL BE CONSIDERED FOR THE NEXT REVISION OF THE RISK ANALYSIS AND WILL BE DOCUMENTED IN EVENT. THE RISK WAS ASSESSED BY TAKING INTO ACCOUNT THE NUMBER OF APPLICATIONS, THE PROBABILITY OF OCCURRENCE OF "FREE FLOW TO THE PATIENT" AND THE PROBABILITY OF THE HAZARDOUS SITUATION LEADING TO THE HARM "ACD OVERDOSE LEADING TO DEATH". AS A RESULT, THE OCCURRENCE OF HARM WAS CALCULATED TO FALL INTO THE CATEGORY "IMPROBABLE". ALTHOUGH THE SEVERITY WAS RATED "CATASTROPHIC, THE OVERALL RISK EVALUATION ENDED IN THE ALAP REGION. TRENDING: NO SIMILAR COMPLAINTS WERE RECEIVED. CONCLUSION: CASE WAS CAUSED BY A COMBINATION OF SEVERAL CONTRIBUTING FACTORS. ON THE DEVICE SIDE, A DEFECTIVE PUMP ROTOR WAS DETECTED. NO SIMILAR CASES ARE KNOWN, THE OCCURRENCE OF RISK WAS ASSESSED AS IMPROBABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279878 FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR LKN FRESENIUS HEMOCARE GMBH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death