BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2132733 · Received June 17, 2011

    Report

    Report Number
    1423500-2011-07764
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 25, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 1 OF 2 INVOLVED IN THIS PERITONITIS EVENT. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS WAS UNDETERMINED. A BATCH REVIEW OF THE POTENTIALLY ASSOCIATED LOT NUMBERS (H11B05010) REVEALED NO EXCEPTIONS DURING THE MANUFACTURING PROCESS. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM (B)(6). THIS IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF PERITONITIS AND NONCOMPLIANT IN A (B)(6) MALE COINCIDENT WITH DIANEAL PD2 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 AMBUFLEX (DOSE, FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE NURSE REPORTED THAT ON AN UNREPORTED DATE IN 2011, THE PATIENT WAS NONCOMPLIANT. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED. TREATMENT INFORMATION WAS NOT REPORTED. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING. DIANEAL THERAPY WAS ONGOING. THE NURSE REPORTED THAT THE EVENT OF PERITONITIS WAS NOT RELATED TO DIANEAL THERAPY. AN OPINION OF CAUSALITY WAS NOT PROVIDED FOR THE EVENT OF NONCOMPLIANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization HOMECHOICE| DIANEAL PD2 AMBUFLEX