BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 3132994 · Received May 29, 2013

    Report

    Report Number
    1416980-2013-13562
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 12, 2013
    Report Date
    May 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED ON POTENTIALLY ASSOCIATED LOT NUMBER 12K14H25 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 4 INVOLVED IN THIS PERITONITIS EVENT. IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS. THERAPIES WERE ONGOING. AS A RESULT OF THE PERITONITIS, THE PATIENT EXPERIENCED DIARRHEA AND STOMACH ISSUES. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS AND THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENT WAS TREATED WITH UNSPECIFIED PROPHYLACTIC ANTIBIOTICS FOR THE PERITONITIS. ON A LATER DATE, THE PATIENT RECOVERED FROM THE PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237110 FLEXICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention MINICAP, MINICAP TRANSFER SET| HOMECHOICE AUTOMATED PD SET WITH CASSETTE| HOMECHOICE, DIANEAL PD4 AMBUFLEX