BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSFER SET

    MDR report key: 2032902 · Received March 29, 2011

    Report

    Report Number
    1423500-2011-03799
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 10, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBERS H10G30067 WERE REVIEWED FOR THIS COMPLAINT. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. THE ASSIGNABLE CAUSE OF THIS PERITONITIS IS USE ERROR-POOR ASEPTIC TECHNIQUE. THE CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE SUSPECTED USE ERROR IN ASEPTIC TECHNIQUE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 5 OF 5 FOR THIS INCIDENCE OF PERITONITIS. AS PATIENT DISCARDS SUPPLIES AFTER EACH USE, A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. FOLLOW UP WILL BE SUBMITTED AS INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) CONTACTED BAXTER ON (B)(6) 2011 FOR AN UNRELATED ALARM AND VERBALIZED THAT SHE HAD PERITONITIS. DURING A FOLLOW CALL ON (B)(6) 2011 WITH THE PERITONEAL DIALYSIS (PD) RN, SHE CONFIRMED THAT THE PATIENT HAD PERITONITIS IN (B)(6) 2011. THE PATIENT WAS TREATED WITH AN UNKNOWN DOSE OF TOBRAMYCIN AND VANCOMYCIN PRIOR TO RECEIVING THE PD CULTURE RESULTS. AFTER THE PD CULTURE WAS RECEIVED (ON AN UNKNOWN DATE) THE PATIENT WAS TREATED WITH VANCOMYCIN AND FORTAZ 1GM INTRAPERITONEALLY FOR 10 DAYS. THE PD RN REPORTED THAT THE PATIENT MAY HAVE FORGOTTEN THE LAST HAND SANITIZING BEFORE STARTING THERAPY. SHE HAS REVIEWED PROPER ASEPTIC TECHNIQUE WITH THE PATIENT. THE PATIENT HAS RECOVERED AND CONTINUES PD THERAPY WITHOUT INCIDENT. THERE WAS NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention DIANEAL LOCAL (PD4) AMBUFLEX| HOME CHOICE CYCLER