BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3243890 · Received July 23, 2013

    Report

    Report Number
    1416980-2013-19527
    Event Type
    Death
    Date Received
    July 23, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBER H13C12012 WAS PERFORMED 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.

    Description of Event or Problem · 1

    IT WAS REPORTED A HOME PATIENT EXPERIENCED PERITONITIS COINCIDENT TO PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. TREATMENT FOR PERITONITIS INCLUDED UNSPECIFIED ANTIBIOTICS. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON A LATER DATE, THE PATIENT DIED DUE TO CARDIAC ARREST. IT WAS UNKNOWN IF THE PATIENT HAD COMPLETED ANTIBIOTIC THERAPY OR IF PERITONITIS HAD RESOLVED PRIOR TO DEATH. THE DEATH CERTIFICATE WAS NOT AVAILABLE AND IT WAS UNKNOWN IF AN AUTOPSY WOULD BE PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 2 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343952 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R MINICAP TRANSFER SET| DIANEAL PD4 AMBUFLEX 1.5% AND 2.5%