BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 3011560 · Received March 19, 2013

    Report

    Report Number
    1416980-2013-06633
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    January 6, 2013
    Report Date
    February 22, 2013
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). . THIS IS THE SAME PATIENT AS (B)(4). THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION NOR USE ERROR. THEREFORE, A SAMPLE WAS NOT REQUESTED AND THE PROBLEM WAS NOT CONFIRMED. THE CAUSE COULD NOT BE DETERMINED. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS 12G18H25 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS, COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS (PD). THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS ON THE SAME DAY. THERAPIES WERE DISCONTINUED, HOWEVER THE TREATMENT WAS NOT REPORTED. TWELVE DAYS LATER THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND THE PATIENT HAS RECOVERED. THIS IS REPORT 1 OF 6 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113734 FLEXICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization DIANEAL PD4 AMBUFLEX| HOMECHOICE