BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2660941 · Received July 19, 2012

    Report

    Report Number
    1423500-2012-14382
    Event Type
    Injury
    Date Received
    July 19, 2012
    Date of Event
    June 1, 2012
    Report Date
    June 26, 2012
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 PERITONITIS. THE COMPLAINT IS CONFIRMED BECAUSE THE NURSE REPORTED THE PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE DURING THE PERITONEAL DIALYSIS PROCEDURE. 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

    THE FOLLOWING INFORMATION WAS RECEIVED BY BAXTER GLOBAL PHARMACOVIGILANCE (GPV) AND IS A REPORT BY A NURSE WITH SUPPLEMENTAL INFORMATION BY A PHYSICIAN IN (B)(6) OF BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS IN A PATIENT (B)(6) COINCIDENT WITH DIANEAL-N PD-4, 1.5% SOLUTION, DIANEAL-N PD-4, 2.5% SOLUTION AND EXTRANEAL SOLUTIONS FOR PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNREPORTED DATE THE PATIENT BEGAN TREATMENT WITH DIANEAL-N PD-4, 1.5% (5.0 LITERS (L), FREQUENCY AND LOT NUMBERS NOT REPORTED), DIANEAL-N PD-4, 2.5% (5.0 L, FREQUENCY AND LOT NUMBERS NOT REPORTED) AND EXTRANEAL (1.5 L, FREQUENCY AND LOT NUMBERS NOT REPORTED) IP (INTRAPERITONEALLY) FOR PD. IT WAS REPORTED THAT ON AN UNSPECIFIED DATE, EXTRANEAL WAS TEMPORARILY DISCONTINUED AND DIANEAL REMAINED ONGOING. ON (B)(6) 2012, THE NURSE CONTACTED BAXTER (B)(4) TECHNICAL SERVICE CENTER AND REPORTED THE FOLLOWING INFORMATION. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS. ON AN UNREPORTED DATE, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE DURING THE PD PROCEDURE (DETAILS NOT PROVIDED). IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED, HOWEVER, DATES OF ADMISSION AND DISCHARGE WERE NOT PROVIDED. REMEDIAL TREATMENT WAS PROVIDED WITH AN UNKNOWN ANTIBIOTIC DRUG. CONCOMITANT THERAPY WAS NOT REPORTED. ON (B)(6) 2012 ADDITIONAL FOLLOW UP INFORMATION WAS PROVIDED FROM A PHYSICIAN WHICH MEDICALLY CONFIRMED THIS CASE. THE OUTCOME OF THE BREAK IN ASEPTIC TECHNIQUE WAS NOT REPORTED. AT THE TIME OF THE REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS. THE PHYSICIAN STATED THE PERITONITIS WAS LIKELY DUE TO AN INFECTIOUS ETIOLOGY AND A BREAK IN ASEPTIC TECHNIQUE DURING THE PD PROCEDURE AND NOT RELATED TO A BAXTER DEVICE OR SOLUTION.

    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 Hospitalization| R DIANEAL-N PD4 1.5% DEXTROSE| DIANEAL-N PD4 2.5% DEXTROSE| EXTRANEAL