BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4140284 · Received October 3, 2014

    Report

    Report Number
    1416980-2014-34387
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 6, 2014
    Report Date
    September 8, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K894783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TITANIUM ADAPTER. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE EVALUATION CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT OF PERITONITIS WAS MANIFESTED BY CLOUDY EFFLUENT, PAIN, AND VOMITING. THE PERITONEAL DIALYSIS NURSE REPORTED THE CAUSE OF PERITONITIS WAS HOME ENVIRONMENT (FURTHER SPECIFICS NOT REPORTED); HOWEVER THE EXACT CAUSE REMAINS UNKNOWN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 6 DAYS AFTER THE EVENT. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT RECOVERED FROM THE PERITONITIS EVENT. PERITONEAL DIALYSIS THERAPY WAS DISCONTINUED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS EVENT WAS UNKNOWN. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH CEFAZOLIN INTRAPERITONEALLY (IP, 1GRAM DAILY WHILE AT HOME) AND VANCOMYCIN IN THE HOSPITAL (DOSE, ROUTE, FREQUENCY AND THERAPY DATES ARE UNKNOWN) FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT WAS NOT RECOVERED FROM PERITONITIS. PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THIS IS REPORT 4 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618421 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R DIANEAL PD4 AMBUFLEX 1.5%, 2.5%, HOMECHOICE| TRANSFER SET, MINICAP AND CASSETTE