BEUDAMED
    FDA Adverse Event Summary report: N

    CENTRISOL LIQUID BICARBONATE CONCENTRATE

    MDR report key: 5853244 · Received August 8, 2016

    Report

    Report Number
    2150060-2016-00031
    Date Received
    August 8, 2016
    Date of Event
    July 25, 2016
    Report Date
    August 5, 2016
    Manufacturer
    MEDIVATORS
    Product Code
    KPO
    UDI-DI
    30677964000400
    PMA / PMN Number
    K843963/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS RECEIVED THROUGH MEDIVATORS DISTRIBUTOR, FRESENIUS MEDICAL CARE (FMC) POST MARKET SURVEILLANCE DEPARTMENT VIA LETTER OF COMPLAINT. IT WAS REPORTED THAT 4 PATIENTS EXPERIENCED NAUSEA AND VOMITING AFTER RECEIVING DIALYSIS. MEDIVATORS LIQUID BICARBONATE CONCENTRATE WAS USED IN THE DIALYSATE SOLUTION FOR PATIENT DIALYSIS TREATMENT. MEDIVATORS RA IMMEDIATELY CONTACTED THIS FACILITY FOR ADDITIONAL INFORMATION. IN THIS DISCUSSION, IT WAS REPORTED THAT ALL PATIENTS ARE CURRENTLY STABLE. ONE PATIENT WAS HOSPITALIZED BECAUSE THEY EXPERIENCED EXTREME VOMITING. ONLY ONE LOT NUMBER WAS PROVIDED (780857) BY THE FACILITY. PRELIMINARY ANALYSIS OF THIS LOT FROM TESTING ON MEDIVATORS' RESERVE SAMPLE AND BATCH RECORD REVIEW DEMONSTRATED THAT THE BICARBONATE MET SPECIFICATION. MEDIVATORS WAS UNABLE TO RECEIVE PRODUCT BACK AND FMC DID NOT PROVIDE LOT INFORMATION. IT WAS ALSO REPORTED THAT THE PATIENTS ALL RECEIVE HOME DIALYSIS USING THE FRESENIUS K@HOME DIALYSIS MACHINE AND FRESENIUS ACID CONCENTRATE. IT WAS MENTIONED THAT THE PATIENTS' MACHINES WERE OPERATING NORMALLY AND DIALYSATE METERS WERE WITHIN THE APPROPRIATE LIMITS PRIOR TO USE. A MEDICAL REPORT WENT OUT TO ALL FRESENIUS DOCTORS AND THEY RESPONDED THAT THERE WAS NO TREND IN THESE SYMPTOMS AMONGST OTHER PATIENTS USING MEDIVATORS LIQUID BICARBONATE SOLUTION. MEDIVATORS RA AND QA MET WITH THE RENAL CLINICAL SPECIALIST TO DISCUSS THIS CASE. IT WAS MENTIONED THAT NAUSEA AND VOMITING IS THE MOST COMMON SIDE-EFFECT FOR PATIENTS ON DIALYSIS. THIS COMPLAINT WILL CONTINUE TO BE MAINTAINED WITHIN MEDIVATORS COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    THE CASE STATES PATIENTS EXPERIENCED NAUSEA AND VOMITING AFTER RECEIVING HEMODIALYSIS TREATMENT. MEDIVATORS LIQUID SODIUM BICARBONATE WAS A COMPONENT USED IN THEIR DIALYSATE SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505486 CENTRISOL LIQUID BICARBONATE CONCENTRATE DIALYSIS CONCENTRATE FOR HEMODIALYSIS KPO MEDIVATORS MB330-L-B 30677964000400

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization FRESENIUS HEMODIALYSIS MACHINE