BEUDAMED
    FDA Adverse Event Death Summary report: N

    NATURALYTE ACID CONCENTRATE

    MDR report key: 7347035 · Received March 16, 2018

    Report

    Report Number
    1225714-2018-00003
    Event Type
    Death
    Date Received
    March 16, 2018
    Date of Event
    January 1, 2014
    Report Date
    March 26, 2018
    Manufacturer
    CORPORATE
    Product Code
    KPO
    PMA / PMN Number
    K981043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DEATH SELECTION: NO CORRECTED DATE OF EVENT: (B)(6) 2014. (B)(4) AFTER THOROUGH REVIEW OF ALL THE AVAILABLE DOCUMENTATION IT HAS BEEN DETERMINED THERE IS NO EVIDENCE, DOCUMENTATION AND/OR INDICATION THAT ANY FRESENIUS DEVICE(S) OR PRODUCT(S) CAUSED OR CONTRIBUTED TO THE ALLEGED ADVERSE EVENT OF SEPSIS.

    Additional Manufacturer Narrative · 1

    NO SAMPLE OR LOT NUMBER IS AVAILABLE. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WITH ADDITIONAL RELEVANT INFORMATION UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ON 02/14/2018 ADDITIONAL DOCUMENTATION, PLAINTIFF'S ORIGINAL PETITION AND REQUEST FOR DISCLOSURE, WAS RECEIVED BY (B)(4) FOR THIS SPECIFIC COMPLAINT FILE (PREVIOUSLY CAPTURED UNDER MFR REPORT #: 1225714-2015-08121). A CLINICAL REVIEW OF THIS ADDITIONAL INFORMATION WAS CONDUCTED, AND DOCUMENTED AN ALLEGATION OF SEPSIS (DATE UNKNOWN) PREVIOUSLY NOT REPORTED IN THE FILE INFORMATION. THE DOCUMENTATION ALLEGED SHORTLY AFTER (DATE UNKNOWN) THE PATIENT WAS INITIATED ON HEMODIALYSIS (HD) THERAPY (IN 2014) THE PATIENT EXPERIENCED A SEPSIS EVENT. DOCUMENTATION CONTAINED IN THE FILE RECORDED THE PATIENT INITIATED HD THERAPY IN 2014, HOWEVER, THERE WAS NO INFORMATION IN THE AVAILABLE DOCUMENTATION REGARDING AN EVENT OF SEPSIS EXPERIENCED IN 2014.

    Description of Event or Problem · 1

    THE DAUGHTER ALLEGED THE PATIENT WAS ADMITTED TO A LONG-TERM SPECIALTY HOSPITAL ON (B)(6) 2015 FOLLOWING A SURGICAL PROCEDURE FOR POST-OPERATIVE TREATMENT, PHYSICAL THERAPY, AND IV THERAPY RELATED TO HER DIABETES. EXPERIENCED FIVE CARDIAC AND/OR RESPIRATORY NONRESPONSIVE EVENTS DUE TO THE INFUSION OF NATURALYTE ACID PRODUCT, AT THE COMMENCEMENTS OF THE DIALYSIS PROCEDURES. THE DAUGHTER ALLEGED THE PATIENT EXPERIENCED LOSS OF CONSCIOUSNESS, HYPOTENSION AND CARDIAC/RESPIRATORY ARREST. THE PATIENT'S DAUGHTER ALLEGED THE PATIENT PRESENTED WITH ADVERSE REACTIONS TO THE DIALYSATE AND CONTINUED TREATMENTS BEYOND THE FIRST ADVERSE EVENTS WHERE SHE BECAME NON-RESPONSIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188748 NATURALYTE ACID CONCENTRATE DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO CORPORATE

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death| H| L| R