BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2182389 · Received July 28, 2011

    Report

    Report Number
    1423500-2011-09885
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 4, 2011
    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). THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS IS USE ERROR - POOR ASEPTIC TECHNIQUE. A BATCH REVIEW OF THE POTENTIALLY ASSOCIATED LOT NUMBERS (H11C26014, H11D19058, H11E06045) REVEALED NO EXCEPTIONS DURING THE MANUFACTURING PROCESS. A LABELING REVIEW WAS PERFORMED AND THE LABELING WAS FOUND TO PROVIDE AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE USE ERROR IN ASEPTIC TECHNIQUE. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EVENT IS UNKNOWN THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AND/OR UPON CONCLUSION OF BAXTER'S INVESTIGATION A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS THE SECOND OF FOUR REPORTS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    BAXTER CONTACTED THE PERITONEAL DIALYSIS NURSE (PDRN) ON (B)(6) 2011 REGARDING A HOME PATIENT (HP) REPORT OF PERITONITIS. THE PDRN STATED THAT THE HP, ON A DATE PREVIOUS TO (B)(6) 2011, EXPERIENCED SYMPTOMS AND WENT TO THE HOSPITAL EMERGENCY ROOM ONLY FOR A PERITONEAL DIALYSIS (PD) EFFLUENT ANALYSIS. THE PDRN STATED THAT THE HP WAS TREATED BUT THAT SHE COULD NOT DISCLOSE FURTHER INFORMATION OTHER THAN THE CAUSALITY WAS THE HP NOT WEARING HIS MASK DURING CONNECTION AND SET UP OF PD THERAPY.

    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 70 YR Required Intervention HOME CHOICE| LOCAL(PD4)AMBUFLEX