BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4912451 · Received July 14, 2015

    Report

    Report Number
    1416980-2015-28753
    Event Type
    Injury
    Date Received
    July 14, 2015
    Date of Event
    May 31, 2015
    Report Date
    June 22, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    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 CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) THERAPY. THERE WAS NO FURTHER DESCRIPTION OF THE BREACH IN ASEPTIC TECHNIQUE. PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT. ON THE DAY OF ONSET, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. BEGINNING ON THE DAY OF ONSET, THE PATIENT WAS TREATED WITH CEFAZOLIN 1 GRAM DAILY INTRAPERITONEALLY FOR FOUR DAYS AND FORTUM 1 GRAM DAILY INTRAPERITONEALLY FOR FOUR DAYS FOR THE PERITONITIS EVENT. FIVE DAYS AFTER ONSET, THE PATIENT BEGAN TREATMENT WITH TIENAM 1 GRAM DAILY INTRAPERITONEALLY FOR EIGHTEEN DAYS AND CIPROFLOXACIN 200 MILLIGRAMS DAILY INTRAPERITONEALLY FOR EIGHTEEN DAYS FOR THE PERITONITIS EVENT. DIANEAL THERAPIES WERE ONGOING. AFTER TWENTY-TWO DAYS OF HOSPITALIZATION, THE PATIENT WAS DISCHARGED. THE PATIENT WAS RECOVERED FROM THE PERITONITIS EVENT. IT WAS NOT REPORTED IF 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
    456230 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R DIANEAL 1.5% AND 2.5% LOW CALCIUM PD4