BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 3250583 · Received July 26, 2013

    Report

    Report Number
    1416980-2013-19911
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    June 7, 2013
    Report Date
    July 1, 2013
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBERS 13A16H25 AND 12L11H25 WAS PERFORMED. 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 SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) EXPERIENCED PERITONITIS. ON THE DAY OF THE ONSET OF PERITONITIS, THE PATIENT WAS HOSPITALIZED. TREATMENT FOR THIS EVENT WAS NOT REPORTED. AFTER TWO WEEKS OF BEING HOSPITALIZED, THE PATIENT WAS DISCHARGED. THE PATIENT WAS RECOVERING FROM PERITONITIS. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 4 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349800 FLEXICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization MINICAP TRANSFER SET| HOMECHOICE| HOMECHOICE AUTOMATED PD SET WITH CASSETTE| MINICAP