BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 3230223 · Received July 16, 2013

    Report

    Report Number
    1416980-2013-18686
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND RECOVERING FROM THE PERITONITIS. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS 13A16H25, 12L11H25 AND 13B18H25 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 4 OF 4 INVOLVED IN THIS EVENT. THIS IS A REPORT OF A PATIENT WHO EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS. ACTION TAKEN WITH THERAPY WAS NOT REPORTED. THE CAUSE OF THE PERITONITIS WAS UNKNOWN AND TREATMENT INFORMATION WAS NOT REPORTED. IT WAS UNKNOWN IF THE PATIENT RECOVERED FROM THE PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328860 FLEXICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization HOMECHOICE AUTOMATED PD SET WITH CASSETTE,| MINICAP TRANSFER SET, MINICAP| HOMECHOICE, DIANEAL, EXTRANEAL VIAFLEX,