BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3930030 · Received July 11, 2014

    Report

    Report Number
    1416980-2014-22379
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    May 26, 2014
    Report Date
    June 17, 2014
    Manufacturer
    BAXTER HEATHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR REPORTED TO BE DUE TO A BREAK IN ASEPTIC TECHNIQUE BY THE PATIENT. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE BREAK IN ASEPTIC TECHNIQUE INCLUDED AN UNSPECIFIED TOUCH CONTAMINATION AND ALSO THE PATIENT DID NOT WEAR A MASK WHILE PERFORMING PERITONEAL DIALYSIS (PD) THERAPY. THE REPORTER FURTHER STATED THAT THE PATIENT WAS ¿ TOO RELAXED WITH SANITARY PRECAUTIONS WHICH LED TO PERITONITIS¿ (NOT FURTHER SPECIFIED). THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS ON THE SAME DAY AS THE UPDATED OCCURRENCE DATE AND WAS DISCHARGED FOUR DAYS LATER. TWENTY TWO DAYS AFTER ONSET (PREVIOUSLY REPORTED AS EIGHTEEN DAYS AFTER ONSET) THE PERITONITIS WAS RESOLVED AND THE PATIENT WAS RECOVERED FROM THE EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY WHICH RESULTED IN PERITONITIS. THE BREAK IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS THE PATIENT DID NOT CLEAN THE EXCHANGE AREA BEFORE STARTING PD THERAPY. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN. THE SAME DAY, THE PATIENT WAS HOSPITALIZED AND BEGAN TREATMENT WITH VANCOMYCIN (1 GRAM ONCE EVERY 4 DAYS, ROUTE UNREPORTED) FOR THE PERITONITIS EVENT. THREE DAYS AFTER ADMISSION TO THE HOSPITAL, THE PATIENT WAS DISCHARGED. EIGHTEEN DAYS AFTER THE ONSET OF PERITONITIS, VANCOMYCIN WAS DISCONTINUED AND THE PATIENT WAS RECOVERED FROM THE EVENT. ON AN UNREPORTED DATE, THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE. PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407871 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEATHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R DIANEAL PD4, 1.5% AMBUFLEX| DIANEAL PD4 2.5% AND 4.25% DIANEAL 2.5% ULTRABAG