BEUDAMED
    FDA Adverse Event Death Summary report: N

    CENTRISOL LIQUID BICARBONATE CONCENTRATE

    MDR report key: 6765625 · Received August 3, 2017

    Report

    Report Number
    2150060-2017-00033
    Event Type
    Death
    Date Received
    August 3, 2017
    Date of Event
    July 10, 2017
    Report Date
    August 3, 2017
    Manufacturer
    MEDIVATORS, INC.
    Product Code
    KPO
    UDI-DI
    00677964000409
    PMA / PMN Number
    K843963
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT STATES: "THE CHARGE NURSE AT THE USER FACILITY REPORTED A PATIENT ADVERSE EVENT THAT OCCURRED SOON AFTER THE HEMODIALYSIS (HD) TREATMENT WAS INITIATED. FURTHER EVENT CLARIFICATION REVEALED THAT APPROXIMATELY 10 MINUTES AFTER INITIATION OF THE HD THERAPY THE PATIENT GASPED, AND THEN CODED. THE TREATMENT WAS CANCELLED, AND THE PATIENT WAS REMOVED FROM THE MACHINE. THE CODE CONTINUED FOR ONE HOUR AND THIRTY MINUTES, AFTER WHICH TIME, THE PATIENT EXPIRED. FOLLOW-UP INFORMATION WAS RECEIVED WHICH REVEALED THAT THE EVENT WAS BELIEVED TO HAVE BEEN CAUSED BY A PULMONARY EMBOLISM (PE). ALTHOUGH REQUESTED, NO FURTHER PATIENT SPECIFIC OR EVENT RELATED DETAILS HAVE BEEN MADE AVAILABLE. NO MACHINE ALARMS WERE GENERATED PRIOR TO, DURING, OR FOLLOWING THE PATIENT INCIDENT." MEDIVATORS CENTRISOL LIQUID SODIUM BICARBONATE CONCENTRATE (45X) WAS BEING USED IN CONJUNCTION WITH NATURALYTE ACID CONCENTRATE FOR THE DIALYSATE SOLUTION IN A FRESENIUS HEMODIALYSIS MACHINE. MEDIVATORS DISTRIBUTOR, (B)(4), RECEIVED NOTICE OF THIS ADVERSE EVENT FROM THE FACILITY ON 05/19/2017. MEDIVATORS RECEIVED A COMPLAINT NOTIFICATION LETTER FROM (B)(4) ON 07/10/2017. BOTH MEDIVATORS AND (B)(4) POST MARKET SURVEILLANCE TEAMS ATTEMPTED TO CONTACT THE FACILITY FOR ADDITIONAL EVENT INFORMATION. THIS FOLLOW UP INFORMATION REPORTED THAT THE EVENT WAS CAUSED BY A PULMONARY EMBOLISM (PE). IT WAS ALSO REPORTED THAT NO DIALYSIS MACHINE ALARMS WERE GENERATED PRIOR TO, DURING, OR FOLLOWING THE PATIENT INCIDENT. IN THESE ATTEMPTS, THE LOT NUMBER OF THE BICARBONATE USED OR ANY PATIENT RELATED INFORMATION WAS NOT PROVIDED/DISCLOSED. THIS COMPLAINT WILL CONTINUE TO BE MONITORED IN MEDIVATORS COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT DURING A HEMODIALYSIS TREATMENT, THE PATIENT GASPED, AND THEN CODED. AFTER CANCELLING THE TREATMENT AND REMOVING THE PATIENT FROM THE MACHINE, THE CODE CONTINUED FOR ONE HOUR AND THIRTY MINUTES, AFTER WHICH TIME, THE PATIENT EXPIRED. IT WAS REPORTED THAT THE ADVERSE EVENT WAS CAUSED BY A PULMONARY EMBOLISM (PE). MEDIVATORS LIQUID BICARBONATE WAS USED IN THE DIALYSATE SOLUTION FOR DIALYSIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543907 CENTRISOL LIQUID BICARBONATE CONCENTRATE DIALYSATE CONCENTRATE FOR HEMODIALYSIS KPO MEDIVATORS, INC. 00677964000409

    Patients

    Seq Age Sex Outcome Treatment
    1 Death