BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1822931 · Received September 1, 2010

    Report

    Report Number
    1423500-2010-03071
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 10, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED, THEREFORE, NO EVALUATION WAS PERFORMED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOMECHOICE PATIENT (HP) WHO STATED SHE HAS BEEN IN AND OUT OF THE HOSPITAL DUE TO A HERNIA AND IS IN A LOT OF PAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2010 FOR ABDOMINAL PAIN AND ACUTE PERITONITIS. THE PATIENT WAS TREATED WITH VANCOMYCIN (DOSE AND ROUTE UNKNOWN). THE PATIENT HAD HER LAST TREATMENT OF PERITONEAL DIALYSIS (PD) THERAPY ON (B)(6) 2010. ON (B)(6) 2010 A CULTURE WAS TAKEN FROM THE PD CATHETER WHICH REVEALED (B)(6). THE CATHETER WAS REMOVED THAT DATE. ON (B)(6) 2010 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT IS CURRENTLY RECEIVING HEMODIALYSIS. THE PERITONITIS WAS REPORTEDLY NOT RELATED TO THE DIANEAL SOLUTIONS. THE OUTCOME OF HERNIA IS UNKNOWN, HOWEVER, THE PATIENT REPORTEDLY DID NOT HAVE SURGERY FOR REPAIR OF THE HERNIA. DURING A FOLLOW UP CALL ON (B)(6) 2010, THE FACILITY NURSE INDICATED THAT THE PERITONITIS WAS DUE TO A BOWEL ISSUE AND UNRELATED TO THE CATHETER, BAXTER DEVICES OR SOLUTIONS. THE PATIENT OUTCOME WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME 21394

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R (B)(4) 1.5% LO/CAL UB 2L/2L DIANEAL (B)(4)