BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 3033668 · Received April 3, 2013

    Report

    Report Number
    1416980-2013-08304
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    February 19, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE NOTED DURING THE PRODUCTION OF THIS BATCH RELATING TO THIS COMPLAINT. THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW UP INFORMATION RECEIVED FROM THE NURSE. THE NURSE STATED THAT SHE HAD SEEN THE PATIENT PERFORM PERITONEAL DIALYSIS (PD) THERAPY AT HOME BEFORE, AND HAD NOT OBSERVED ANY BREACH IN ASEPTIC TECHNIQUE. ON AN UNREPORTED DATE, THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE. PD THERAPY WAS ONGOING AT THE TIME OF THIS REPORT. A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBER, 12I18H25 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED.

    Description of Event or Problem · 1

    THIS IS REPORT 3 OF 5. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF PERITONITIS WAS UNKNOWN. TREATMENT WAS NOT REPORTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL EIGHT DAYS LATER. THE PATIENT RECOVERED FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136349 FLEXICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG