BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2833443 · Received November 15, 2012

    Report

    Report Number
    1416980-2012-05221
    Event Type
    Death
    Date Received
    November 15, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 22, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, A BATCH REVIEW WAS NOT PERFORMED. A SAMPLE IS NOT REQUIRED FOR USE ERROR AS THERE IS NO ALLEGATION AGAINST THE DEVICE. THIS REPORT OF A USE ERROR - BREACH IN ASEPTIC TECHNIQUE WAS CONFIRMED, AS IT WAS REPORTED THERE WAS A BREAK IN ASEPTIC TECHNIQUE. THE BREAK IN ASEPTIC TECHNIQUE WAS DESCRIBED AS A MISTAKE WHILE PERFORMING PD THERAPY. HOWEVER, THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. INSTRUCTIONS RELATED TO THE REPORTED PROBLEM ARE CONTAINED IN THE PRODUCT LABELING, ARE ACCURATE AND SUFFICIENT, AND EASILY ACCESSIBLE BY THE PATIENT. NO ISSUES WERE IDENTIFIED WITH THE PRODUCT LABELING THAT WOULD CONTRIBUTE TO THE REPORTED PROBLEM. 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.

    Additional Manufacturer Narrative · 1

    (B)(4): THE PATIENT EXPERIENCED CARDIAC DISEASE, HYPERTENSION, AND SEIZURES. TREATMENT FOR THESE EVENTS WAS NOT REPORTED. ON AN UNKNOWN DATE IN (B)(6) 2012, THE PATIENT DIED DUE TO CARDIAC DISEASE, HYPERTENSION AND SEIZURES. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. IT WAS UNKNOWN IF PERITONEAL DIALYSIS THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. THE PATIENT HAD NOT RECOVERED FROM THE PERITONITIS EVENT AT THE TIME OF DEATH. THE REPORTED CONDITION REMAINS CONFIRMED BECAUSE A BREAK IN ASEPTIC TECHNIQUE CAUSED THE PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT FROM A CONSUMER FROM (B)(6). THIS REPORT IS OF A BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED, FURTHER SPECIFIED AS A PATIENT THAT MADE A MISTAKE WHILE PERFORMING PD THERAPY. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF PERITONITIS WAS A BREAK IN ASEPTIC TECHNIQUE. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH AN INJECTION (INJ) OF NEOMYCIN (IP, 50MG) AND AN INJ OF TARGOCID (IP, 400MG), ALTERNATIVE BAGS FOR PERITONITIS. DIANEAL THERAPY WAS ONGOING. OUTCOME OF THE PERITONITIS WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE. THE CONSUMER REPORTED THE PERITONITIS WAS UNRELATED TO DIANEAL THERAPY. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE TO INDIA PHARMACOVIGILANCE TO QUERY THE REPORTER OR A HEALTH CARE PROFESSIONAL. THE QUERY WAS TO DETERMINE IF THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE. INDIA PHARMACOVIGILANCE MADE DUE DILIGENCE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, BUT NO NEW INFORMATION WAS RECEIVED AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R DIANEAL 2.5% ULTRABAG