BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4231978 · Received November 6, 2014

    Report

    Report Number
    1416980-2014-39109
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    June 25, 2014
    Report Date
    October 13, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN, FURTHER DESCRIBED AS ¿THE PATIENT HAD A HOME NURSE CHANGE¿ (NO FURTHER DETAILS PROVIDED). ON THE SAME DAY AS ONSET, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED FOR THE PERITONITIS WITH SULPERAZON INTRAVENOUS (IV) (ACTIVE SUBSTANCE: SULBACTUM SODIUM + CEFOPERAZONE SODIUM) AND SEFAZOL 12.1 (ACTIVE SUBSTANCE: CEFAZOLIN SODIUM), (UNREPORTED DOSES, AND FREQUENCIES). THIRTEEN DAYS AFTER ONSET, THE PATIENT WAS RECOVERED FROM THE PERITONITIS EVENT AND WAS DISCHARGED FROM THE HOSPITAL ON THE SAME DAY. ON AN UNREPORTED DATE, RETRAINED ON PERFORMING PD THERAPY AND ASEPTIC TECHNIQUE WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 2 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715069 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization| R DIANEAL PD4, TRANSFER SET AND MINICAP