BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2902358 · Received January 8, 2013

    Report

    Report Number
    1416980-2013-00560
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 17, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF PERITONITIS IS NOT CONFIRMED AND THE CAUSE WAS NOT IDENTIFIED BECAUSE THE DISPOSABLE SET WAS NOT RETURNED TO BAXTER, LOT NUMBER WAS NOT PROVIDED FOR A BATCH REVIEW AND THE USER DID NOT DESCRIBE ANY TYPES OF MALFUNCTIONS, USE ERRORS OR OTHER ISSUES THAT MIGHT HAVE CAUSED THE REPORTED PROBLEM.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 1 OF 3. THE LOT NUMBER WAS UNKNOWN AND A SAMPLE WAS NOT AVAILABLE. SINCE THE LOT NUMBER IS UNKNOWN, A BATCH REVIEW WILL NOT BE PERFORMED. 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. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A PATIENT CONTACTED BAXTER TECHNICAL SERVICES (BTS) AND REPORTED HE HAD PERITONITIS. ON (B)(6) 2012, PRODUCT SURVEILLANCE CONTACTED THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) REGARDING THE PERITONITIS EVENT AND THE FOLLOWING INFORMATION WAS OBTAINED. ON (B)(6) 2012, THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNKNOWN DATE IN (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED FOR THE EVENT. THE NURSE INDICATED, THE PATIENT WAS ON VACATION AND HOSPITALIZED IN (B)(6); THEREFORE, THE AMOUNT OF INFORMATION SHE HAD PERTAINING TO THE EVENT WAS LIMITED. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH AN UNSPECIFIED ANTIBIOTIC THERAPY, SO THE NURSE ASSUMED THE PERITONITIS WAS A BACTERIAL INFECTION. AT THE TIME OF THIS REPORT, THE PERITONITIS WAS ONGOING BUT THE PATIENT WAS RECOVERING. PD THERAPY WAS ONGOING. IT WAS UNKNOWN IF THE PATIENT REMAINED HOSPITALIZED AT THIS TIME. THE NURSE STATED THE PERITONITIS WAS UNRELATED TO ANY BAXTER SOLUTIONS, DISPOSABLES OR DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9761 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R HOMECHOICE| DIANEAL PD4 AMBUFLEX| DIANEAL PD4 ULTRABAG