BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2614026 · Received June 12, 2012

    Report

    Report Number
    1423500-2012-12420
    Event Type
    Injury
    Date Received
    June 12, 2012
    Date of Event
    May 1, 2012
    Report Date
    May 19, 2012
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A USE ERROR - BREACH IN ASEPTIC TECHNIQUE AND SERIOUS INJURY. THE COMPLAINT IS CONFIRMED BECAUSE THE NURSE REPORTED A BREAK IN ASEPTIC TECHNIQUE DESCRIBED AS TOUCH CONTAMINATION. THE ASSIGNABLE CAUSE WAS NOT 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 FROM A CONSUMER WITH SUPPLEMENTAL INFORMATION PROVIDED BY A NURSE IN THE USA OF PERITONITIS WITH CULTURE POSITIVE FOR STREPTOCOCCUS IN A PATIENT COINCIDENT WITH UNSPECIFIED DIANEAL THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH UNSPECIFIED DIANEAL SOLUTION THERAPY (DOSES, FREQUENCIES AND LOT NUMBERS NOTE REPORTED) INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) THERAPY. INITIALLY THE HOME PATIENT?S (HP) CAREGIVER (CG) CONTACTED BAXTER TECHNICAL SERVICE TO REQUEST ASSISTANCE WITH ADDING ANTIBIOTIC (UNSPECIFIED) TO PERITONEAL DIALYSIS (PD) SOLUTION BAGS FOR PERITONEAL DIALYSIS (PD) THERAPY. THE CG STATED "THE NURSE GAVE THE HOME PATIENT (HP) BAGS BECAUSE HE HAS AN INFECTION", AND SHE WAS WONDERING WHEN SHE PUTS THE ANTIBIOTICS IN THE BAGS? THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE CG TO CALL THE PATIENT'S PERITONEAL DIALYSIS NURSE (PDN) TO OBTAIN THE REQUESTED INFORMATION. ON (B)(4) 2012, BAXTER PRODUCT SURVEILLANCE MADE CONTACT WITH THE PDN TO FOLLOW UP ON THE REPORTED INCIDENT. THE NURSE REPORTED THE PATIENT EXPERIENCED A TOUCH/CONTAMINATION (DETAILS NOT PROVIDED) THAT RESULTED IN A STREPTOCOCCUS INFECTION. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2012 FOR ABDOMINAL PAIN AND WAS THEN DIAGNOSED WITH PERITONITIS. THE NURSE REPORTED THE PATIENT WAS RETRAINED REGARDING PROPER ASEPTIC TECHNIQUE DURING PD THERAPY. THE OUTCOME OF THE PERITONITIS EVENT WAS UNKNOWN. NO FURTHER INFORMATION WAS AVAILABLE REGARDING THIS PERITONITIS EVENT.

    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 53 YR Hospitalization| R