BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3022777 · Received March 27, 2013

    Report

    Report Number
    1416980-2013-07370
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 4, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS ANIMAL DAMAGE TO THE PATIENT LINE. PER BAXTER LABELING, USERS ARE INSTRUCTED TO NOT ALLOW ANIMALS IN THE ROOM WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED A PATIENT EXPERIENCED RECURRENT PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY IN (B)(6) 2013. ON AN UNKNOWN DATE IN (B)(6) 2013, THE PATIENT'S PD CATHETER WAS REMOVED DUE TO THE PERITONITIS. THE PATIENT THEN DISCONTINUED PD THERAPY AND STARTED HEMODIALYSIS. ON AN UNKNOWN DATE IN 2013 THE PATIENT WAS RECOVERED FROM PERITONITIS. CONFIRMATION FROM THE PERITONEAL DIALYSIS REGISTERED NURSE AND THE NEPHROLOGIST WAS OBTAINED STATING THAT THE PERITONITIS IN (B)(6) 2013 WAS RECURRENT FROM A PREVIOUSLY REPORTED PERITONITIS IN (B)(6) 2013. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOME PATIENT (HP) WHO WAS HOSPITALIZED AND DIAGNOSED WITH PERITONITIS DUE TO THE CAT BITING THROUGH THE LINE. TREATMENT WAS NOT REPORTED. THE HP WAS REPORTED TO BE RECOVERING AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125767 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization DIANEAL 4.25% AND HOMECHOICE| DIANEAL PD4 2.5% SOLUTION