BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2008T HEMODIALYSIS SYS., WITH CDX

    MDR report key: 6011930 · Received October 7, 2016

    Report

    Report Number
    2937457-2016-01101
    Event Type
    Injury
    Date Received
    October 7, 2016
    Date of Event
    September 15, 2016
    Report Date
    November 3, 2016
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K093902
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION OF THE UNIT WAS PERFORMED BY A FRESENIUS REGIONAL EQUIPMENT SPECIALIST (RES) AND NO PARTS WERE RETURNED FOR FAILURE ANALYSIS. FOLLOW-UP INFORMATION WAS PROVIDED BY THE BIOMEDICAL TECHNICIAN WHO REVEALED THAT A TEAR WAS IDENTIFIED IN THE HOSE CONNECTED TO THE RED HANSEN LINE (DRAIN LINE) OF THE HD MACHINE WHICH RESULTED IN A FLUID LEAK. THE BIOMED REMOVED THE TORN PIECE OF HOSE TO REPAIR THE LINE AND RESOLVE THE ISSUE. FUNCTIONAL TESTING PERFORMED BY THE BIOMED CONFIRMED THE SYSTEM WAS OPERATING PROPERLY. THE UNIT HAS BEEN RETURNED TO SERVICE AT THE USER FACILITY WITHOUT A RECURRENCE OF THE EVENT AS REPORTED. A RECORDS REVIEW WAS PERFORMED ON THE REPORTED SERIAL NUMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). NO PARTS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY. CLINICAL EVALUATION: THE PATIENT MEDICAL RECORDS WERE PROVIDED BY THE FACILITY ON SEPTEMBER 30, 2016. A CLINICAL INVESTIGATION WAS PERFORMED TO IDENTIFY A CAUSAL RELATIONSHIP BETWEEN THE HEMODIALYSIS TREATMENT AND THE ADVERSE EVENT. A (B)(6), AFRICAN AMERICAN MALE PATIENT EXPERIENCED AN EPISODE OF SYNCOPE APPROXIMATELY 3 HOURS AFTER THE INITIATION OF THE HEMODIALYSIS (HD) TREATMENT. THE NURSE REPORTED THAT THE MACHINE GENERATED A "FAILED ONLINE CLEARANCE (OLC)" ALARM AND WHEN SHE RESPONDED THE PATIENT WAS FOUND TO BE UNRESPONSIVE AND DIAPHORETIC. THE PATIENT'S BLOOD PRESSURE (B/P) DROPPED TO 60/39 (BP HAD BEEN RUNNING SYSTOLIC 115 TO 125 AND DIASTOLIC 72 TO 78 CONSISTENTLY DURING THE TREATMENT), PULSE REMAINED CLOSE TO BASELINE AT 57 AS DID THE PATIENT'S RESPIRATORY RATE (RR) OF 16. ULTRA-FILTRATION WAS TURNED OFF AND THE PATIENT WAS PLACED IN THE SUPINE POSITION. THE PATIENT WAS ADMINISTERED 400ML OF NORMAL SALINE AND RECOVERED CONSCIOUSNESS. AFTER APPROXIMATELY 10 MINUTES, THE PATIENT WAS NOTED AS BEING ALERT WITH NO SIGNS OR SYMPTOMS OF DISTRESS. THE PATIENT WAS RETURNED TO A SITTING UP POSITION AND B/P WAS RECORDED AT 152/77, PULSE 58, RR 16. FOLLOWING THE EVENT, THE NURSE REPORTED THAT THE HD MACHINE HAD MULTIPLE ALARMS FOR HIGH ARTERIAL AND VENOUS PRESSURES, AND HIGH TRANSMEMBRANE PRESSURE (TMP). THE NURSE FLUSHED THE LINES WITH 200ML OF NORMAL SALINE IN AN ATTEMPT TO CLEAR THE ALARMS; NO SIGNS OR SYMPTOM OF AN INFILTRATE WERE NOTED. HOWEVER, THE HIGH VENOUS, ARTERIAL, AND TMP ALARMS CONTINUED WITHOUT RESOLVE. THE HD TREATMENT WAS TERMINATED APPROXIMATELY 40 MINUTES EARLIER THAN EXPECTED. THE NURSE EXPERIENCED DIFFICULTY CLEARING THE VENOUS LINE AND DIALYZER WHILE RETURNING THE BLOOD. NO SIGNS OR SYMPTOMS OF CLOTTING IN THE VENOUS CHAMBER OR STREAKING IN THE DIALYZER WERE OBSERVED. THE NURSE INDICATED THAT APPROXIMATELY 100ML OF BLOOD WAS LEFT IN THE EXTRACORPOREAL CIRCUIT AND DISCARDED AT THE CONCLUSION OF THE TREATMENT. THEREFORE, THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS NOTED AS BEING 100ML. THIS WAS REPORTED AS BEING DONE INTENTIONALLY AS TO PREVENT FLUID OVERLOAD, SINCE THE PATIENT'S VITAL SIGNS AND MENTATION HAD RETURNED TO A NORMAL STATE. ADDITIONALLY, THE NURSE REPORTED THAT THE MACHINE TOOK OFF 3000ML MORE FLUID THAN WAS INTENDED. HOWEVER, THE PATIENT SUFFERED NO ADVERSE EFFECTS AND WAS DISCHARGED HOME WITH NO ADDITIONAL INTERVENTION WARRANTED. THE PATIENT RESUMED AND COMPLETED THEIR NEXT REGULARLY SCHEDULED HD TREATMENT TWO DAYS LATER WITHOUT INCIDENT. THE PATIENT HAS A SIGNIFICANT MEDICAL HISTORY INCLUDING A CORONARY ARTERY BYPASS GRAFT (CABG), HYPERTENSION, DIABETES MELLITUS WITH RENAL MANIFESTATIONS, AND CHRONIC KIDNEY DISEASE (CKD). ADDITIONALLY, THE PATIENT TAKES A NUMBER OF MEDICATIONS RELATED TO THE NOTED COMORBIDITIES. THE POSSIBILITY EXISTS THAT THE EPISODE OF SYNCOPE EXPERIENCED BY THE PATIENT COULD BE RELATED TO THE COMORBIDITIES, THE MEDICATIONS, OR A COMBINATION OF THE TWO. BASED ON THE PROVIDED MEDICAL RECORDS, ALONG WITH THE INFORMATION CAPTURED WITHIN THE COMPLAINT FILE, IT IS NOT POSSIBLE TO CONFIRM THAT A CAUSAL RELATIONSHIP EXISTS BETWEEN THE HD TREATMENT AND THE SYNCOPAL EVENT. ALTHOUGH THE PROVIDED TREATMENT DATA SHEETS, AND THE FOLLOW-UP PROVIDED BY THE USER FACILITY REVEAL THAT EXCESS FLUID WAS REMOVED DURING THE HD TREATMENT, A DEFINITIVE CONCLUSION IS NOT POSSIBLE WITHOUT KNOWING THE RELATIONSHIP AND POTENTIAL IMPACT OF THE PATIENT¿S UNDERLYING HEALTH ISSUES, COMORBIDITIES, AND THE PRESCRIBED MEDICATIONS ON THE PATIENT¿S OVERALL HEALTH.

    Description of Event or Problem · 1

    A BIOMEDICAL TECHNICIAN (BMT) AT THE USER FACILITY REPORTED THAT A PATIENT EXPERIENCED AN EPISODE OF SYNCOPE APPROXIMATELY 3 HOURS INTO THEIR HEMODIALYSIS (HD) TREATMENT. THE HD THERAPY WAS INITIATED AT 10:50 AM. THE NURSE REPORTED THAT THE MACHINE GENERATED A "FAILED ONLINE CLEARANCE (OLC)" ALARM AND WHEN SHE RESPONDED THE PATIENT WAS FOUND TO BE UNRESPONSIVE AND DIAPHORETIC. ULTRA-FILTRATION WAS TURNED OFF AND THE PATIENT WAS PLACED IN THE SUPINE POSITION. THE PATIENT WAS ADMINISTERED 400ML OF NORMAL SALINE AND RECOVERED CONSCIOUSNESS. AFTER APPROXIMATELY 10 MINUTES, THE PATIENT WAS NOTED AS BEING ALERT WITH NO SIGNS OR SYMPTOMS OF DISTRESS. THE PATIENT WAS RETURNED TO A SITTING UP POSITION, AND THEN THE TREATMENT WAS RESTARTED. SHORTLY AFTER TREATMENT WAS RESUMED, THE NURSE REPORTED THAT THE HD MACHINE HAD MULTIPLE ALARMS FOR HIGH ARTERIAL AND VENOUS PRESSURE, AND HIGH TRANSMEMBRANE PRESSURE (TMP). THE NURSE FLUSHED THE LINES WITH 200ML OF NORMAL SALINE IN AN ATTEMPT TO CLEAR THE ALARMS; NO SIGNS OR SYMPTOM OF AN INFILTRATE WERE NOTED. HOWEVER, THE HIGH VENOUS, ARTERIAL, AND TMP ALARMS CONTINUED WITHOUT RESOLVE. AT THIS TIME A LARGE AMOUNT OF CLEAR FLUID WAS NOTED TO BE LEAKING FROM THE BACK OF THE MACHINE. THE PATIENT REMAINED STABLE DURING THIS PERIOD WITH NO COMPLAINTS. AT 2:10 PM, THE HD TREATMENT WAS TERMINATED WHICH WAS 40 MINUTES EARLIER THAN EXPECTED. THE NURSE EXPERIENCED DIFFICULTY CLEARING THE VENOUS LINE AND DIALYZER WHILE RETURNING THE BLOOD. NO SIGNS OR SYMPTOMS OF CLOTTING IN THE VENOUS CHAMBER OR STREAKING IN THE DIALYZER WERE OBSERVED. THE NURSE INDICATED THAT APPROXIMATELY 100ML OF BLOOD WAS LEFT IN THE EXTRACORPOREAL CIRCUIT AND DISCARDED AT THE CONCLUSION OF THE TREATMENT. THEREFORE, THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS NOTED AS BEING 100ML. THE WAS REPORTED AS BEING INTENTIONAL AS TO PREVENT FLUID OVERLOAD, SINCE THE PATIENT'S VITAL SIGNS AND MENTATION HAD RETURNED TO A NORMAL STATE. ADDITIONALLY, THE NURSE REPORTED THAT THE MACHINE TOOK OFF 3000ML MORE FLUID THAN WAS INTENDED. HOWEVER, THE PATIENT SUFFERED NO ADVERSE EFFECTS AND WAS DISCHARGED HOME WITH NO ADDITIONAL INTERVENTION WARRANTED. THE PATIENT RESUMED AND COMPLETED THEIR NEXT REGULARLY SCHEDULED HD TREATMENT TWO DAYS LATER WITHOUT INCIDENT. THE BIOMED REPORTED THAT UPON INSPECTION OF THE HD MACHINE, A TEAR WAS IDENTIFIED IN THE HOSE CONNECTED TO THE RED HANSEN LINE (DRAIN LINE) WHICH RESULTED IN A FLUID LEAK. THE BIOMED REMOVED THE TORN PIECE OF HOSE TO REPAIR THE LINE AND RESOLVE THE ISSUE. FUNCTIONAL TESTING PERFORMED BY THE BIOMED CONFIRMED THE SYSTEM WAS OPERATING PROPERLY. THE UNIT HAS BEEN RETURNED TO SERVICE AT THE USER FACILITY WITH NO RECURRENCE OF THE EVENT AS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663063 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI FRESENIUS MEDICAL CARE NORTH AMERICA 2008T

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention