BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 4002361 · Received August 12, 2014

    Report

    Report Number
    1416980-2014-26153
    Event Type
    Injury
    Date Received
    August 12, 2014
    Date of Event
    June 24, 2014
    Report Date
    July 18, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS 14A15H25 AND 13J15H25. THERE WERE NO ISSUES DETECTED DURING THE MANUFACTURING PROCESSES. AS THE SAMPLE WAS NOT RETURNED, A DEVICE EVALUATION CANNOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED BACTERIAL PERITONITIS MANIFESTED BY CLOUDY EFFLUENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON THE SAME DAY AS THE ONSET, THE PATIENT WAS TREATED WITH CEFEPIME (3 TIMES PER WEEK, DOSE AND ROUTE NOT REPORTED) FOR PERITONITIS AND WAS ONGOING AT THE TIME OF THIS REPORT. APPROXIMATELY A MONTH LATER, THE PATIENT¿S PD CATHETER WAS REMOVED AND REPLACED. THE PATIENT¿S OUTCOME WAS ONGOING AND IMPROVING AT THE TIME OF THIS REPORT. DIANEAL THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480470 FLEXICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention HOMECHOICE AUTOMATED PD SET WITH CASSETTE| DIANEAL 1.5% AND 2.5% PD4 ULTRABAG,| DIANEAL 1.5% AND 2.5% PD4 AMBUFLEX,| HOMECHOICE, MINICAP, CAPD DISCONNECT Y SET,| MINICAP TRANSFER SET,