BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4860251 · Received June 22, 2015

    Report

    Report Number
    1416980-2015-26164
    Event Type
    Injury
    Date Received
    June 22, 2015
    Date of Event
    May 27, 2015
    Report Date
    June 5, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS FOR A BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE BREACH IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS THE SUPPLIES FOR PERITONEAL DIALYSIS WERE NOT SET UP CORRECTLY. PERITONITIS WAS MANIFESTED BY ABDOMINAL CRAMPS AND CLOUDY EFFLUENT. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS EVENT. ON THE DAY OF ONSET, THE PATIENT WAS TREATED WITH VANCOMYCIN 1500 MILLIGRAMS INTRAPERITONEALLY FOR A ONE TIME DOSE FOR THE PERITONITIS EVENT. BEGINNING ON THE DAY OF ONSET, THE PATIENT WAS TREATED WITH CEFTAZIDIME 1 GRAM DAILY INTRAPERITONEALLY (DURATION NOT REPORTED) FOR THE PERITONITIS EVENT. TREATMENT WITH CEFTAZIDIME WAS ONGOING AND TEN DAYS AFTER THE INITIAL RECEIPT OF THIS REPORT, THE PATIENT WAS REPORTED TO HAVE TWO MORE DOSES OF CEFTAZIDIME TREATMENT UNTIL COMPLETION. BEGINNING THREE DAYS AFTER THE ONSET OF PERITONITIS, THE PATIENT WAS TREATED WITH VANCOMYCIN 1000 MILLIGRAMS EVERY THREE DAYS INTRAPERITONEALLY (DURATION NOT REPORTED) FOR THE PERITONITIS EVENT. TREATMENT WITH INTRAPERITONEAL VANCOMYCIN WAS DISCONTINUED ON AN UNKNOWN DATE IN THE MONTH FOLLOWING THE ONSET OF THE PERITONITIS EVENT. DIANEAL THERAPIES WERE ONGOING. THE PATIENT WAS RECOVERING FROM THE PERITONITIS EVENT. THE PATIENT WAS RETRAINED ON THE PROPER ASEPTIC TECHNIQUE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404410 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention HOMECHOICE| DIANEAL 1.5% AND 2.5% LOW CALCIUM SINGLEBAG