BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXTENSION SET

    MDR report key: 3803269 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-15090
    Event Type
    Death
    Date Received
    May 9, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 16, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. THIS REPORT REFERENCES THE SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13K20050, H14A21024, AND H14A30017 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PERITONITIS WAS MANIFESTED BY ¿ABDOMINAL BLOATING, PAIN, CONSTIPATION AND A LUMP ON THE RIGHT SIDE OF THE NAVAL¿. FOUR DAYS LATER THE PATIENT WAS HOSPITALIZED. ON AN UNREPORTED DATE THE PATIENT WAS TREATED WITH VANCOMYCIN (DOSE, ROUTE AND FREQUENCY NOT REPORTED) AND OTHER UNSPECIFIED ANTIBIOTICS FOR THE PERITONITIS EVENT. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE SAME DAY AS HOSPITALIZATION PD THERAPY WAS DISCONTINUED. ONE DAY AFTER BEING HOSPITALIZED ¿COMFORT CARE WAS PROVIDED¿ AND SUBSEQUENTLY THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED AS END STAGE RENAL DISEASE, PNEUMONIA, AND SEPSIS. IT WAS REPORTED THE PERITONITIS EVENT DID NOT RESOLVE PRIOR TO THE DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280596 EXTENSION SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| H| R HOMECHOICE, CAPD DISCONNECT Y SET| HOMECHOICE AUTOMATED PD SET WITH CASSETTE| DIANEAL PD4 2.5% SOLUTION, MINICAP