BEUDAMED
    FDA Adverse Event Death Summary report: N

    2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS

    MDR report key: 6096593 · Received November 11, 2016

    Report

    Report Number
    2937457-2016-01141
    Event Type
    Death
    Date Received
    November 11, 2016
    Date of Event
    October 3, 2016
    Report Date
    November 11, 2016
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DATE OF DEATH IS NOT KNOWN, HOWEVER, THE NURSE INDICATED THAT THE PATIENT EXPIRED ON EITHER ON (B)(4) 2016. PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. MANUFACTURING INVESTIGATION: THE 2008K HD MACHINE WAS EVALUATED AT THE FACILITY BY THE FRESENIUS RES. FUNCTIONAL TESTING WAS PERFORMED BY THE RES WHICH CONFIRMED THE UNIT WAS OPERATING AS REQUIRED. ALL TESTS FOUND THE UNIT TO BE FUNCTIONING WITHIN SPECIFICATIONS. IT IS NOT CURRENTLY KNOWN IF THE UNIT HAS BEEN RETURNED TO SERVICE AT THE USER FACILITY. 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 NON-CONFORMANCES OR ANY ASSOCIATED REWORK DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE LABELING AND QUALITY CONTROL TESTING RESULTS WERE WITHIN SPECIFICATIONS. CLINICAL INVESTIGATION: WHILE REQUESTED, NO MEDICAL RECORDS HAVE BEEN RECEIVED. THERE ARE NO ALLEGATIONS AGAINST THE 2008K HD MACHINE OR ANY OTHER FRESENIUS PRODUCTS AND THE PATIENTS TRANSITORY ONE TO TWO MINUTES OF BEING UNRESPONSIVE OR THEIR SUBSEQUENT EXPIRATION. ALTHOUGH THERE IS A TEMPORAL ASSOCIATION INVOLVING THE 2008K HD MACHINE AND NATURALYTE, IT IS UNLIKELY THAT A CAUSAL RELATIONSHIP EXISTS. THE INVESTIGATION INTO THE PATIENT INCIDENT WAS NOT ABLE TO CONFIRM A DEVICE ISSUE WHICH WOULD HAVE RESULTED IN THE ADVERSE EVENT. NO DEVICE MALFUNCTIONS WERE ALLEGED, IDENTIFIED, OR OBSERVED PRIOR TO, DURING, OR FOLLOWING THE PATIENTS HD TREATMENT. THE MACHINE WAS REMOVED FROM SERVICE AFTER THIS EVENT AND EVALUATED BY THE FRESENIUS RES. ALL TESTS FOUND THE UNIT TO BE FUNCTIONING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A BIOMEDICAL ENGINEER (BIOMED) AT A USER FACILITY REPORTED THAT A PATIENT REQUESTED SERVICE ON A 2008K HEMODIALYSIS (HD) MACHINE FOLLOWING A PATIENT INCIDENT INVOLVING AN AIR EMBOLISM. FOLLOW-UP INFORMATION WITH THE NURSE AT THE USER FACILITY REVEALED THAT THE PATIENT WAS A CHRONIC HD PATIENT. THE PATIENT HAD ARRIVED FOR TREATMENT LOOKING PALE AND HAD TREMORS. APPROXIMATELY 20 MINUTES INTO THE TREATMENT, THE PATIENT BLANKED OUT, THE PATIENTS EYES BECAME FIXED AND PUPILS CONSTRICTED. THE PATIENTS VITALS WERE STABLE, BUT THE PATIENT REMAINED PALE. THE NURSE STATED THAT WITHIN A MATTER OF A MINUTE OR TWO MINUTES, THE PATIENT BECAME RESPONSIVE. THE PHYSICIAN TERMINATED TREATMENT AND THE PATIENT WENT BACK TO HER ROOM. APPROXIMATELY 3 HOURS LATER, THE FLOOR STAFF FOUND THE PATIENT UNRESPONSIVE IN HER ROOM. THE STAFF VENTILATED THE PATIENT AND A BRAIN SCAN REVEALED THAT HER BRAIN WAS GONE. THE PATIENT CAME OFF OF THE VENTILATOR EITHER TWO OR THREE DAYS LATER AT WHICH TIME THE PATIENT EXPIRED. THE NURSE STATED THAT THE PATIENT HAS HAD EXISTING PROBLEMS WITH HER ACCESS AND HAD OTHER PROBLEMS RELATED TO HER HEALTH. THREE DAYS BEFORE THE INCIDENT, A CATHETER LINE WAS PLACED BY THE O.R. DOCTOR AND X-RAYS SHOWED THAT THE CATHETER WAS PLACED CORRECTLY. HOWEVER, ON THE MORNING OF THE INCIDENT, THE CATHETER HAD BEEN PULLED AND IT WAS NOTED THEN THAT THE CATHETER WAS IN FACT NOT PLACED CORRECTLY. IT WAS SOMETIME AFTER A 4 HOUR PERIOD THAT THE TREATMENT IN QUESTION HAD BEEN INITIATED. THE NURSE CONFIRMED THAT THERE WAS NO AIR EMBOLISM THAT OCCURRED WHILE THE PATIENT WAS ON THE HD MACHINE AND NO AIR NOTED IN THE BLOODLINES DURING THE PATIENTS TREATMENT. THE MACHINE PASSED ALL SET-UP AND SELF TESTS PRIOR TO THE START OF TREATMENT AND DID NOT ALARM DURING THE PATIENTS TREATMENT. FRESENIUS BRAND NATURALYTE WAS ALSO USED AT THE TIME OF THE HD TREATMENT. NO ACID CONCENTRATE SAMPLES HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER FOR EVALUATION. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE 2008K HD MACHINE WAS PULLED FROM SERVICE FOLLOWING THE EVENT IN ORDER TO PERFORM AN EVALUATION. THE USER FACILITYS ON-SITE BIOMED CHECKED THE MACHINE AND DID NOT FIND ANY ISSUES. IN ADDITION, THE MACHINE WAS EVALUATED BY A FRESENIUS REGIONAL EQUIPMENT SPECIALIST (RES). THE RES CHECKED ALL PUMPS AS WELL AS THE AIR LEVEL AND BLOOD LEAK DETECTORS FOR ACCURACY. THE RES CONFIRMED THAT THE UNIT WAS OPERATING PROPERLY AND ALL SYSTEMS WERE OPERATING WITHIN ACCEPTABLE LIMITS. NO INFORMATION HAD BEEN MADE AVAILABLE TO CONFIRM IF THE UNIT HAS BEEN RETURNED TO SERVICE AT THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746806 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI CONCORD MANUFACTURING 2008K

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R GAMBRO DIALYZER| MINNTECH BICARBONATE| NIPRO BLOODLINES