BEUDAMED
    FDA Adverse Event Death Summary report: N

    NATURALYTE DRY PACK RX-12

    MDR report key: 5774856 · Received July 7, 2016

    Report

    Report Number
    1651896-2016-00003
    Event Type
    Death
    Date Received
    July 7, 2016
    Date of Event
    June 7, 2016
    Report Date
    September 13, 2016
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K981043
    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

    THE REPORTED COMPLAINT IS NOT CONFIRMED AS A COMPLAINT SAMPLE WAS NOT AVAILABLE FOR MANUFACTURER EVALUATION AND A LOT NUMBER WAS NOT PROVIDED. AS SUCH, A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT SAMPLE. A REVIEW OF THE PRODUCT DELIVERY HISTORY REVEALED ONE LOT OF PRODUCT DELIVERED TO THE FACILITY IN THE THREE MONTHS PRIOR TO THE EVENT; THE DISTRIBUTION CENTER WAS ABLE TO PROVIDE A PRODUCT RETAIN FROM THE REPORTED LOT NUMBER FOR TESTING. RETAIN TESTING FOUND ANALYTE CONCENTRATIONS TO BE WITHIN THE SPECIFICATION RANGE WITH ANALYTE VALUES NEAR THEIR NOMINAL LEVELS. TEST RESULTS ARE ALSO COMPARABLE TO ORIGINAL FINISHED PRODUCT RELEASE RESULTS DOCUMENTED IN THE DEVICE HISTORY RECORD (DHR) FOR THE REPORTED PRODUCT LOT NUMBER. FINISHED PRODUCT TEST RESULTS CONFIRMED THAT THE LOT MET ALL APPLICABLE RELEASE CRITERIA. ADDITIONALLY, FOLLOW-UP INFORMATION WAS PROVIDED BY THE USER FACILITY WHICH REVEALED THAT NO MALFUNCTION OF THE HEMODIALYSIS MACHINE WAS ALLEGED, OBSERVED, OR IDENTIFIED DURING THE PATIENT'S HD TREATMENT. DURING THE POST EVENT MACHINE EVALUATION A SMALL LEAK WAS NOTED ON THE ACID PUMP WHICH WAS REBUILT AND RECALIBRATED. THE BICARB PUMP WAS ALSO REBUILT AS A PRECAUTIONARY MEASURE. FOLLOWING THESE EVENTS, THE MACHINE PASSED ALL FUNCTIONAL AND HYDRAULIC TESTING. A RECORDS REVIEW WAS PERFORMED ON THE REPORTED LOT. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. THE LOT PASSED ALL RELEASE CRITERIA. A DEFINITIVE CONCLUSION REGARDING THE INVOLVEMENT OF THE CONCENTRATE PRODUCT COULD NOT BE REACHED WITHOUT A PHYSICAL ANALYSIS OF THE DIALYSATE USED DURING THE REPORTED EVENT. A RETROSPECTIVE REVIEW OF THE BATCH PRODUCTION RECORD (BPR) DID NOT IDENTIFY ANY NONCONFORMANCE'S AND/OR ABNORMALITIES DURING PRODUCTION THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THEREFORE, NO EVIDENCE OF A MANUFACTURING PROBLEM EXISTS TO SUBSTANTIATE A CAUSAL RELATIONSHIP BETWEEN THE CONCENTRATE PRODUCT AND THE REPORTED EVENT. NATURALYTE DRY PACK BICARBONATE CONCENTRATE PRODUCTS ARE MANUFACTURED TO MEET AAMI REQUIREMENTS USING VALIDATED PROCESSES, AND RELEASED BASED ON A DETERMINATION THAT THE FINISHED PRODUCT MET THOSE REQUIREMENTS. A DEFINITIVE CONCLUSION REGARDING THE INVOLVEMENT OF THE PRODUCT COULD NOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF A COMPLAINT SAMPLE. 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 NATURALYTE DRY PACK BICARBONATE CONCENTRATE PRODUCT AND THE PATIENT'S 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
    428690 NATURALYTE DRY PACK RX-12 DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death FRESENIUS BLOODLINE