BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2950472 · Received February 8, 2013

    Report

    Report Number
    1416980-2013-03297
    Event Type
    Death
    Date Received
    February 8, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 16, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE IS NOT AVAILABLE. AN INTERNAL INVESTIGATION IS CURRENTLY UNDER WAY, HOWEVER HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    INCORRECTLY POPULATED AS SERIOUS INJURY. CORRECTED TO REFLECT THE DEATH REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR PERITONITIS-NO MALFUNCTION OR USE ERROR WHERE THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS DUE TO PERITONITIS AMONGST OTHER UNSPECIFIED COMPLICATIONS, BUT THIS COMPLAINT IS NOT CONFIRMED BECAUSE PERITONITIS WAS NOT DUE TO A BREACH IN ASEPTIC TECHNIQUE OR DEVICE MALFUNCTION. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED ON H12J08017 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE CAUSE OF THIS EVENT IS NOT CLASSIFIABLE DUE TO INSUFFICIENT INFORMATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A REPORT OF FATAL PERITONITIS COINCIDENT WITH DIANEAL THERAPIES. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED BY THE CONSUMER. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS. THE PATIENT DIED DUE TO THE PERITONITIS AND OTHER COMPLICATIONS (NOT SPECIFIED). ADDITIONAL INFORMATION WAS OBTAINED BY BAXTER FROM A NURSE. ACCORDING TO THE HOSPITAL, THE REPORTED CAUSE OF DEATH WAS LISTED AS AN ABDOMINAL INFECTION (PERITONITIS), PERFORATED BOWEL, DIVERTICULAR DISEASE, AND GALLBLADDER WITH SECONDARY CAUSE OF GASTROINTESTINAL (GI) HEMORRHAGE. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS BUT WAS, HOWEVER, GIVEN THE ANTIBIOTICS CEFEPIME AND FLAGYL (DOSES, FREQUENCIES, ROUTE AND LOT NUMBERS NOT REPORTED). PER THE RN, THE PERITONITIS WAS NOT RELATED TO BAXTER SOLUTIONS, DEVICES OR DISPOSABLE PRODUCTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54733 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| R DIANEAL PD2 1.5% AND 2.5%