BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4062531 · Received September 5, 2014

    Report

    Report Number
    1416980-2014-29657
    Event Type
    Injury
    Date Received
    September 5, 2014
    Date of Event
    August 9, 2014
    Report Date
    August 11, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K894783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TITANIUM ADAPTER. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. 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 AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY MANIFESTED BY CLOUDY EFFLUENT. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON THE SAME DAY AS ONSET, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, DURING HOSPITALIZATION, THE PATIENT BEGAN TREATMENT FOR THE PERITONITIS WITH CEFTRIAXONE (DOSE AND FREQUENCY NOT REPORTED) INTRAVENOUSLY (IV) AND AT THE TIME OF THIS REPORT, THIS TREATMENT WAS ONGOING. ON AN UNREPORTED DATE, DURING HOSPITALIZATION, THE PATIENT WAS TREATED FOR THE PERITONITIS WITH AN UNSPECIFIED ANTIBIOTIC ORALLY. NINE DAYS AFTER BEING ADMITTED TO THE HOSPITAL, THE PATIENT WAS RECOVERED AND WAS DISCHARGED. AFTER DISCHARGE, TREATMENT FOR THE PERITONITIS WITH ORAL ANTIBIOTICS (UNSPECIFIED) WAS TO CONTINUE FOR THE NEXT TEN DAYS. AT THE TIME OF THIS REPORT, DIANEAL THERAPIES WERE ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 2 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544823 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R TRANSFER SET, CASSETTE, MINICAP, HOMECHOICE| DIANEAL PD4 1.5% AND 2.5% AMBUFLEX,