BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2780900 · Received October 10, 2012

    Report

    Report Number
    1416980-2012-01987
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 19, 2012
    Manufacturer
    BAXTER HEALTHCARE
    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 SAMPLE IS NOT REQUIRED FOR USE ERROR AS THERE IS NO ALLEGATION AGAINST THE DEVICE. 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. THIS REPORT OF USE ERROR - BREACH IN ASEPTIC TECHNIQUE IS CONFIRMED BECAUSE IT WAS REPORTED THERE WAS A BREAK IN ASEPTIC TECHNIQUE BY THE USER DESCRIBED AS MADE A MISTAKE/TOUCH CONTAMINATION. 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.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT FROM A CONSUMER OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION, PERITONITIS AND PAIN IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2012, THE PATIENT CONTACTED BAXTER CUSTOMER SERVICES. THE FOLLOWING INFORMATION WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT BEGAN PD THERAPY. ON AN UNREPORTED DATE, THE PATIENT MADE A MISTAKE/TOUCH CONTAMINATION. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS DUE TO PATIENT MADE MISTAKE/TOUCH CONTAMINATION AND WAS HOSPITALIZED ON THE SAME DAY. TREATMENT WAS NOT REPORTED. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED. PD THERAPY WAS ONGOING. THE PATIENT STILL HAD PAIN WHILE AT HOME. OUTCOME OF PERITONITIS WAS UNKNOWN. IT WAS NOT REPORTED IF THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE. ON (B)(6) 2012, CUSTOMER SERVICES CONTACTED THE PERITONEAL DIALYSIS REGISTERED NURSE REGARDING THE EVENT. THE NURSE STATED THE PERITONITIS WAS NOT RELATED TO PD SOLUTIONS BUT DECLINED TO PROVIDE ANY FURTHER INFORMATION.

    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 60 YR Hospitalization DIANEAL PD4 ULTRABAG| DIANEAL PD4 AMBUFLEX| HOMECHOICE