BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM, DIALYSATE DELIVERY, CENTRAL MULTIPLE PATIENT

    MDR report key: 17529488 · Received August 12, 2023

    Report

    Report Number
    MW5136414
    Event Type
    Death
    Date Received
    August 12, 2023
    Report Date
    July 7, 2017
    Manufacturer
    MEDIVATORS
    Product Code
    FKQ
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    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. THE BICARB CONCENTRATE USED FOR THE HD TREATMENT WAS A NON-FRESENIUS MANUFACTURED PRODUCT. BICARBONATE: MEDIVATORS, LIQUID SODIUM BICARB 45X-4 BO CENTRISOL, LOT#: UNKNOWN NI. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763196 SYSTEM, DIALYSATE DELIVERY, CENTRAL MULTIPLE PATIENT SYSTEM, DIALYSATE DELIVERY, CENTRAL MULTIPLE PATIENT FKQ MEDIVATORS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown