BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2964342 · Received February 15, 2013

    Report

    Report Number
    1416980-2013-03989
    Event Type
    Death
    Date Received
    February 15, 2013
    Report Date
    January 17, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ONSET OF THE PERITONITIS IS UNKNOWN. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOME PATIENT (HP) WHO HAD EXPERIENCED ABDOMINAL PAIN AND WAS HOSPITALIZED AND SUBSEQUENTLY DIAGNOSED WITH PERITONITIS MANIFESTED BY PURULENT MATTER IN THE PERITONEAL CAVITY. UNSPECIFIED IV ANTIBIOTIC THERAPY WAS STARTED. THE HP WAS NOT RESPONDING TO IV TREATMENT AND EXPLORATORY SURGERY WAS PERFORMED. THE SURGERY REVEALED POCKETS OF PURULENT MATTER IN THE PERITONEAL CAVITY. TREATMENT RENDERED WAS NOT REPORTED. THE HP DIED OF MYOCARDIAL INFARCTION (MI) AND SEPSIS DUE TO PERITONITIS. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. THE CAUSE OF PERITONITIS WAS UNKNOWN, ALTHOUGH THE NURSE BELIEVED THAT THERE WERE CONTRIBUTING FACTORS. THE HP WAS HAVING A DIFFICULT TIME DEALING WITH THE RECENT DEATH OF HIS WIFE, WHICH LEAD TO THE DETERIORATION IN HIS OWN SELF CARE, INCLUDING SKIPPING PERITONEAL DIALYSIS TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66598 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death| H| R DIANEAL PD4 AMBUFLEX, EXTRANEAL