BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2821544 · Received November 6, 2012

    Report

    Report Number
    1416980-2012-04191
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 12, 2012
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A SAMPLE WAS NOT REQUESTED BECAUSE THE EVENT INVOLVED USE ERROR AND THERE WAS NO ALLEGATION AGAINST THE DEVICE. THIS CONDITION OF A USE ERROR - BREACH IN ASEPTIC TECHNIQUE AND SERIOUS INJURY WAS CONFIRMED BECAUSE THE NURSE REPORTED A BREAK IN ASEPTIC TECHNIQUE. THE BREAK IN ASEPTIC TECHNIQUE WAS DESCRIBED AS TOUCH CONTAMINATION. NO ASSIGNABLE CAUSE WAS DETERMINED. A LABELING REVIEW WAS PERFORMED WHICH FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. THE LABELING REVIEW CONFIRMED, INSTRUCTIONS RELEVANT TO THE COMPLAINT ARE DOCUMENTED IN THE PRODUCT LABELING AND ARE EASILY ACCESSIBLE TO THE USER. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS IS A REPORT BY A CONSUMER, WITH SUPPLEMENTAL INFORMATION FROM A NURSE, IN THE USA. THIS REPORT IS OF A PATIENT THAT MADE A MISTAKE OF TOUCH CONTAMINATION AND WAS FOUND WITH PERITONITIS, IN COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX THERAPIES (DOSES, FREQUENCIES, AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DIANEAL THERAPIES WERE ONGOING. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING INFORMATION WAS REPORTED BY THE PATIENT'S WIFE. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS, HOWEVER THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. AT THE TIME OF THIS REPORT, THE PATIENT WAS REPORTED TO BE RECOVERING. DURING A FOLLOW UP CALL WITH THE PERITONEAL DIALYSIS NURSE (PDN), THE FOLLOWING ADDITIONAL INFORMATION WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT MADE A MISTAKE OF TOUCH CONTAMINATION (DETAILS NOT PROVIDED). THE PDN CLARIFIED THAT THE PATIENT EXPERIENCED PERITONITIS ON (B)(6) 2012. THE PDN CONFIRMED THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. TREATMENT RENDERED WAS NOT REPORTED. CONCOMITANT THERAPY WAS NOT REPORTED. THE PDN REPORTED THE CAUSE OF THE PERITONITIS WAS DUE TO THE TOUCH CONTAMINATION AND NOT RELATED TO A BAXTER DEVICE OR SOLUTION. ON (B)(6) 2012, BAXTER PRODUCT SURVEILLANCE CONTACTED THE PDN AND RECEIVED ADDITIONAL INFORMATION. THE PDN REPORTED THE PATIENT HAS FULLY RECOVERED FROM THE EVENT OF PERITONITIS. THE PDN CONFIRMED THE PATIENT HAS BEEN RE-TRAINED IN PROPER ASEPTIC PROCEDURES FOR PD THERAPY (DATE UNSPECIFIED).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other DIANEAL PD4 AMBUFLEX