BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4171075 · Received October 14, 2014

    Report

    Report Number
    1416980-2014-35844
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 18, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR DESCRIBED AS BREAK IN ASEPTIC TECHNIQUE. 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). ADDITIONAL INFORMATION: DURING FOLLOW UP IT WAS REPORTED THAT THE PATIENT STARTED ANTIBIOTICS TREATMENT ON (B)(6) 2014 (PREVIOUSLY REPORTED AS (B)(6) 2014).TREATMENT WITH VANCOMYCIN WAS DISCONTINUED ON (B)(6) 2014 AND TREATMENT WITH CEFTAZIDIME WAS DISCONTINUED ON (B)(6) 2014. THE PATIENT WAS REPORTED TO HAVE RECOVERED FROM THE EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY WHILE USING UNKNOWN BAXTER PD DISPOSABLES, WHICH CAUSED PERITONITIS. THE PERITONITIS WAS MANIFESTED BY CLOUDY EFFLUENT AND ABDOMINAL PAIN. THE BREAK IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS THE PATIENT NOT WEARING A MASK. THREE DAYS LATER, THE PATIENT BEGAN TREATMENT WITH VANCOMYCIN IP (1GRAM EVERY 3DAYS) AND CEFTAZIDIME IP (1GRAM PER DAY) FOR PERITONITIS. ON THE SAME DAY, THE PATIENT WAS RE-TRAINED ON PROPER ASEPTIC TECHNIQUE. TWO DAYS LATER, WHEN THE PERITONEAL CULTURE RESULTS WERE KNOWN, THE TREATMENT WITH VANCOMYCIN WAS SUSPENDED. THE TREATMENT WITH CEFTAZIDIME WAS MAINTAINED. THE EVENTS DID NOT REQUIRE HOSPITALIZATION OR PERITONEAL DIALYSIS (PD) THERAPY SUSPENSION. EXTRANEAL, PHYSIONEAL AND NUTRINEAL THERAPIES WERE ONGOING. THE PATIENT OUTCOME WAS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650850 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention EXTRANEAL, PHYSIONEAL, NUTRINEAL| EXTRANEAL, PHYSIONEAL, NUTRINEAL