BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET

    MDR report key: 2063377 · Received April 19, 2011

    Report

    Report Number
    1423500-2011-04712
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    June 1, 2009
    Report Date
    March 25, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K833065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT ADDRESSES THE SECOND REPORT OF PERITONITIS. THIS IS REPORT 2 OF 4 FOR THE SECOND INCIDENCE OF REPORTED PERITONITIS. AS PATIENT DISCARDS SUPPLIES AFTER EACH USE, A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. FOLLOW UP WILL BE SUBMITTED AS INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR LOT NUMBERS HO9E14092, HO9E27060, HO9G07084, WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. THE ASSIGNABLE CAUSE OF THE REPORTED PROBLEM OF PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS AND WILL CONTINUE TO MONITOR THESE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    DURING A FOLLOW UP PHONE CALL WITH THE CUSTOMER FOR AN UNRELATED ALARM COMPLAINT , THE HP REPORTED THAT HE HAD 2 EPISODES OF PERITONITIS 6 MONTHS APART FROM ONE ANOTHER IN 2009. HE COULD NOT RECALL THE CULTURE RESULTS FOR THESE PERITONITIS INCIDENTS. BAXTER CONTACTED THE PD RN ON (B)(6) 2011 AND SHE REPORTED THAT SHE HAS NO INFORMATION AVAILABLE REGARDING THESE PERITONITIS INCIDENTS AS THE INFORMATION FOR THE YEAR 2009 HAS BEEN ARCHIVED. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other DIANEAL LOCAL (PD4) AMBUFLEX| HOMECHOICE