BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2091543 · Received May 17, 2011

    Report

    Report Number
    1423500-2011-06063
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    February 1, 2011
    Report Date
    April 28, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT NUMBER H10K18073 WITH NO DEFECTS NOTED. A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBER H10L08064 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE CAUSE OF THE PERITONITIS WAS USE ERROR-POOR ASEPTIC TECHNIQUE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. 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) AND IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM (B)(6) OF A PATIENT NOT ADHERING TO TRAINED PROCEDURES, KIDNEY INFECTION, AND PERITONITIS WITH (B)(6) COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE CONSUMER REPORTED THE FOLLOWING. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED AN UNSPECIFIED KIDNEY INFECTION. ON AN UNREPORTED DATE, THE PATIENT WAS DIAGNOSED WITH AND HOSPITALIZED FOR PERITONITIS. DURING A FOLLOW-UP CALL WITH THE PATIENT'S PD NURSE, IT WAS REPORTED THAT ON AN UNREPORTED DATE, THE PATIENT WAS NOT ADHERING TO TRAINED PROCEDURES REGARDING PD ADMINISTRATION. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. TREATMENT WAS NOT REPORTED. ON AN UNREPORTED DATE IN 2011, THE PATIENT RECOVERED FROM THE PERITONITIS. THE OUTCOMES FOR THE KIDNEY INFECTION AND PATIENT NOT ADHERING TO TRAINED PROCEDURES WERE NOT REPORTED. PD THERAPY WAS ONGOING. THE NURSE STATED THE PERITONITIS WAS NOT RELATED TO PD THERAPY AND DID NOT COMMENT ON THE KIDNEY INFECTION OR THE PATIENT NOT ADHERING TO TRAINED PROCEDURES.

    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 59 YR Hospitalization DIANEAL PD4 AMBUFLEX| HOMECHOICE