BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2111441 · Received June 2, 2011

    Report

    Report Number
    1423500-2011-06972
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 13, 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). THIS IS REPORT 1 OF 4 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). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBER H10K20061. AN EXCEPTION WAS NOTED, BUT DOES NOT INDICATE ANY ISSUES RELATED TO THE COMPLAINT. A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBER H10L22024 WITH NO DEVIATIONS FROM STANDARD PROCEDURE. THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS WAS UNDETERMINED. 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 GLOBAL PHARMACOVIGILANCE. THIS IS A SPONTANEOUS REPORT FROM A CONSUMER IN THE USA OF PERITONITIS COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (DOSE AND FREQUENCY WERE NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE CONSUMER REPORTED THE FOLLOWING. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED. IT WAS UNKNOWN IF AN EFFLUENT CULTURE WAS PERFORMED. TREATMENT INFORMATION WAS NOT REPORTED. ON AN UNREPORTED DATE, DIANEAL THERAPY WAS WITHDRAWN. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED. THE PATIENT WAS RECOVERING. AN OPINION OF CAUSALITY WAS NOT REPORTED.

    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 68 YR Hospitalization HOMECHOICE DEVICE| DIANEAL PD4 AMBUFLEX