BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4123610 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33531
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 3, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE TRANSFER SET WAS ADDED AND THE CASSETTE WAS REMOVED. THE REPORTED PRODUCT IS AN UNKNOWN BAXTER CASSETTE. UPON FOLLOW UP, IT WAS REPORTED THAT THE PATIENT RECOVERED FROM THE PERITONITIS EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TRANSFER SET. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. THE CAUSE IS NOT IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PERITONITIS WAS MANIFESTED BY CLOUDY EFFLUENT AND TWO DAYS PRIOR TO THE RECEIPT OF THIS REPORT, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF THE PERITONITIS WAS UNKNOWN, FURTHER DESCRIBED AS THE PATIENT ¿MAY NOT HAVE WASHED HIS HANDS THIS ONE TIME¿ HOWEVER, THIS WAS NOT CONFIRMED. ONE DAY AFTER BEING ADMITTED, THE PATIENT BEGAN TREATMENT FOR THE PERITONITIS WITH GENTAMICIN (DOSE, FREQUENCY AND ROUTE OF ADMINISTRATION NOT REPORTED) AND ON THE SAME DAY THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, THE PERITONITIS WAS RESOLVING, THE PATIENT WAS RECOVERING, AND DIANEAL THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 3 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600018 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R DIANEAL PD4, 2.5% AMBUFLEX| CASSETTE, MINICAP, HOMECHOICE| DIANEAL PD4 1.5% AND 2.5% ULTRABAG, TRANSFER SET| PLASTIC ADAPTER (NON-BAXTER PRODUCT),