BEUDAMED
    FDA Adverse Event Death Summary report: N

    2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS

    MDR report key: 5998632 · Received October 4, 2016

    Report

    Report Number
    2937457-2016-01067
    Event Type
    Death
    Date Received
    October 4, 2016
    Date of Event
    September 9, 2016
    Report Date
    November 15, 2016
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. THE 2008K2 HD MACHINE WAS PULLED FROM SERVICE FOLLOWING THE EVENT IN ORDER TO PERFORM AN EVALUATION. THE USER FACILITYS ON-SITE BIOMED PERFORMED ALL PREVENTATIVE MAINTENANCE CHECKS AND FOUND NO ISSUES. THE BIOMED ALSO CALIBRATED THE TEMPERATURE CONTROL AS IT WAS 0.28 DEGREES OFF AND REPLACED THE HINGE PANEL ON THE LEVEL DETECTOR DOOR FOR AESTHETICS. THE UNIT HAS BEEN RETURNED TO SERVICE AT THE USER FACILITY WITHOUT ISSUE. 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. NO MEDICAL RECORDS WERE MADE AVAILABLE; THEREFORE, THERE IS NO WAY TO CONFIRM A CAUSAL RELATIONSHIP BETWEEN THE 2008K2 HEMODIALYSIS (HD) MACHINE AND THE ADVERSE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE FILED UPON COMPLETION OF THIS ACTIVITY. NO MEDICAL RECORDS WERE MADE AVAILABLE; THEREFORE, THERE IS NO WAY TO CONFIRM A CAUSAL RELATIONSHIP BETWEEN THE 2008K2 HEMODIALYSIS (HD) MACHINE AND THE PATIENT'S CARDIAC ARREST AND SUBSEQUENT DEATH.

    Description of Event or Problem · 1

    A BIOMEDICAL ENGINEER (BIOMED) AT A USER FACILITY REPORTED THAT A PATIENT CODED WHILE UNDERGOING HEMODIALYSIS (HD) TREATMENT ON A 2008K2 HEMODIALYSIS (HD) MACHINE AND SUBSEQUENTLY EXPIRED. APPROXIMATELY 14 MINUTES INTO THE TREATMENT, THE PATIENT COMPLAINED OF SHORTNESS OF BREATH. THE STAFF TURNED OFF THE ULTRAFILTRATION (UF) AND ELEVATED THE PATIENT¿S LEGS. IT WAS REPORTED THAT THE MACHINE DID NOT GIVE ANY AUDIBLE ALARMS OR DIAGNOSTIC MESSAGES. SHORTLY AFTER, THE PATIENT CODED. THE STAFF HAD LAID THE PATIENT BACK AND DURING ASSISTANCE, THE ARTERIAL NEEDLE BECAME DISLODGED. PRESSURE WAS APPLIED TO THE SITE, HOWEVER, THE PATIENT DID NOT RESPOND AND EXPIRED. IT WAS REPORTED THAT THE PATIENT WAS RECENTLY RELEASED FROM THE HOSPITAL. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE REGARDING THE INCIDENT. THE 2008K2 HD MACHINE WAS PULLED FROM SERVICE FOLLOWING THE EVENT IN ORDER TO PERFORM AN EVALUATION. THE USER FACILITY¿S ON-SITE BIOMED PERFORMED ALL PREVENTATIVE MAINTENANCE CHECKS AND FOUND NO ISSUES. THE BIOMED ALSO CALIBRATED THE TEMPERATURE CONTROL AS IT WAS 0.28 DEGREES OFF AND REPLACED THE HINGE PANEL ON THE LEVEL DETECTOR DOOR FOR AESTHETICS. THE UNIT HAS BEEN RETURNED TO SERVICE AT THE USER FACILITY WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649968 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI FRESENIUS MEDICAL CARE NORTH AMERICA 2008K2

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death