BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4182514 · Received October 17, 2014

    Report

    Report Number
    1416980-2014-36372
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 21, 2014
    Report Date
    September 23, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS WHICH CAUSED PERITONITIS. THE BREAK IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS THE PATIENT WAS IN AN UNCLEAN ENVIRONMENT. THE PERITONITIS WAS MANIFESTED BY CLOUDY EFFLUENT AND AN ELEVATED WHITE BLOOD CELL COUNT. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT BUT WAS TREATED IN THE EMERGENCY ROOM AND THROUGH THE DIALYSIS CLINIC. IN THE MONTH PRIOR TO THE RECEIPT OF THIS REPORT, THE PATIENT WAS TREATED WITH ANCEF 1 GRAM INTRAPERITONEALLY THROUGH TWENTY DAYS PRIOR TO THIS REPORT. TEN DAYS PRIOR TO THE RECEIPT OF THIS REPORT, THE PATIENT WAS RESTARTED ON ANCEF (1 GRAM DAILY INTRAPERITONEALLY) AND ANTIBIOTIC THERAPY WAS ONGOING AT THE TIME OF THIS REPORT. THE PATIENT WAS REPORTED TO BE ¿MOSTLY RECOVERED¿ FROM THE PERITONITIS EVENT, BUT THE FACILITY HAS CONTINUED TO OBTAIN AND ASSESS PERITONEAL EFFLUENT CULTURES. IT WAS NOT REPORTED IF THE PATIENT WAS RETRAINED ON PROPER ASEPTIC TECHNIQUE. THE CAUSE OF THIS PERITONITIS WAS USE ERROR. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. 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. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH AUTOMATED PERITONEAL DIALYSIS THERAPY. ALTHOUGH THE CAUSE OF THE PERITONITIS WAS UNKNOWN, IT WAS NOTED THAT THE PATIENT HAD BEEN PERFORMING THERAPY IN A POTENTIALLY COMPROMISED ENVIRONMENT. THE PATIENT WAS HOSPITALIZED FOR THE EVENT AND TREATED WITH GENTAMYCIN INTRAVENOUSLY (DOSE, FREQUENCY, AND DURATION NOT REPORTED). UPON DISCHARGE FROM THE HOSPITAL, THE PATIENT BEGAN TREATMENT WITH AN UNSPECIFIED ANTIBIOTIC INTRAPERITONEALLY (DOSE, FREQUENCY, AND DURATION NOT REPORTED) FOR THE PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT HAD RECOVERED FROM THE PERITONITIS. DIANEAL THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660551 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R MINICAP, CASSETTE, FLEXICAP| HOMECHOICE, DIANEAL PD4 AMBUFLEX