BEUDAMED
    FDA Adverse Event Death Summary report: N

    2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS

    MDR report key: 5774846 · Received July 7, 2016

    Report

    Report Number
    2937457-2016-00699
    Event Type
    Death
    Date Received
    July 7, 2016
    Date of Event
    June 7, 2016
    Report Date
    August 31, 2016
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE POST MARKET SURVEILLANCE IS IN THE PROCESS OF REQUESTING MEDICAL RECORDS AND TREATMENT DATA IN RELATION TO THIS EVENT. THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED AT THE COMPLETION OF THIS ACTIVITY.

    Additional Manufacturer Narrative · 1

    NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE 2008K2 HEMODIALYSIS (HD) MACHINE WAS EVALUATED AT THE FACILITY BY THE FRESENIUS REGIONAL EQUIPMENT SPECIALIST (RES). FUNCTIONAL TESTING WAS PERFORMED BY THE RES WHICH FOUND A SMALL LEAK ON THE ACID PUMP. THE RES RE-BUILT, AND THEN CALIBRATED THE ACID PUMP TO RESOLVE THE ISSUE. ADDITIONALLY, THE BICARB PUMP WAS REBUILT AS A PRECAUTIONARY MEASURE. FOLLOWING THE SERVICE ACTIVITY, THE MACHINE PASSED ALL HYDRAULIC AND FUNCTIONAL TESTING. ALL TESTS FOUND THE UNIT TO BE FUNCTIONING WITHIN SPECIFICATION. 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 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. THE INVESTIGATION INTO THE PATIENT INCIDENT WAS NOT ABLE TO CONFIRM A DEVICE ISSUE WHICH WOULD HAVE RESULTED IN THE ADVERSE EVENT. NO MALFUNCTION OF THE 2008K2 HD MACHINE WAS ALLEGED, OBSERVED, OR IDENTIFIED DURING THE PATIENT¿S HD TREATMENT. FURTHERMORE, NO SYSTEM ALARMS WERE GENERATED OR DIAGNOSTIC MESSAGES OCCURRED. ADDITIONALLY, 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 EXPIRATION.

    Description of Event or Problem · 1

    A BIOMEDICAL TECHNICIAN (BMT) AT THE USER FACILITY CALLED TECHNICAL SUPPORT REQUESTING FIELD INVESTIGATION OF A 2008K2 HEMODIALYSIS (HD) MACHINE AFTER A PATIENT EXPIRED DURING THEIR HEMODIALYSIS TREATMENT. THE BMT REPORTED THAT THE POST EVENT DIALYSATE SAMPLE SODIUM RESULTS WERE ELEVATED AT 148MEQ/L. THE MACHINE HAD BEEN PROGRAMMED TO DELIVER SODIUM AT 140MEQ/L. NO MACHINE MALFUNCTION ALLEGED, OBSERVED, OR IDENTIFIED DURING THE PATIENT'S HD TREATMENT. FURTHERMORE, NO SYSTEM ALARMS WERE GENERATED OR DIAGNOSTIC MESSAGES OCCURRED. NO ADDITIONAL EVENT OR PATIENT DETAILS WERE PROVIDED UPON FOLLOW UP WITH THE CLINIC MANAGER AT THE USER FACILITY. THE MACHINE WAS NOT YET RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428616 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 Death