BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3130610 · Received May 24, 2013

    Report

    Report Number
    1416980-2013-13423
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 4, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS REPORTED AS UNKNOWN. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS. IT WAS REPORTED THE PT EXPERIENCED BACTERIAL PERITONITIS MANIFESTED BY CLOUDY EFFLUENT, ABDOMINAL DISCOMFORT, STOMACH PAIN, FEVER, AND CHILLS. THE PT WAS NOT HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE THE PT RECEIVED TREATMENT FOR THE PERITONITIS WITH GENTAMICIN AND CEFAZOLIN, IP, (DOSES, FREQUENCIES, AND LOTS UNKNOWN). THE CAUSE OF THE PERITONITIS WAS UNKNOWN. PD THERAPY WAS ONGOING. AT THE TIME OF THIS REPORT, THE PT WAS RECOVERING FROM THE PERITONITIS. THIS IS REPORT 1 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231499 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention MINICAP TRANSFER SET| DIANEAL PD4 2.5% , LOW CALCIUM AMBUFLEX| MINICAP| FLEXICAP| DIANEAL PD4, LOW CALCIUM ULTRABAG