BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2883605 · Received December 21, 2012

    Report

    Report Number
    1416980-2012-07933
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    August 1, 2012
    Report Date
    November 28, 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 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. THIS EVENT INVOLVED A USE ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION; THEREFORE, A SAMPLE WAS NOT REQUESTED. THIS REPORT OF A USE ERROR, BREACH IN ASEPTIC TECHNIQUE AND PERITONITIS, WAS CONFIRMED AS IT WAS REPORTED BY THE NURSE THAT THERE WAS A TOUCH CONTAMINATION BY THE PATIENT. THE ASSIGNABLE CAUSE WAS UNDETERMINED. A LABELING REVIEW WAS PERFORMED AND THE LABELING WAS FOUND TO PROVIDE AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE USE ERROR IN ASEPTIC TECHNIQUE. 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 THE CONSUMER IN THE USA, OF PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN PD TREATMENT. ON AN UNREPORTED DATE, PD THERAPY WAS WITHDRAWN. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING INFORMATION WAS REPORTED. ON AN UNKNOWN DATE IN AUGUST, THE PATIENT EXPERIENCED PERITONITIS. ON AN UNKNOWN DATE, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT STATED THAT HE WAS IN THE HOSPITAL FOR 10 DAYS. HOWEVER, TREATMENT WAS NOT REPORTED. ON AN UNKNOWN DATE, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. THE PATIENT STATED THAT HE DID NOT DO ANYTHING WRONG. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE PERITONITIS. AN OPINION OF CAUSALITY WAS NOT REPORTED FOR THE EVENT OF PERITONITIS. ON (B)(6) 2012, FOLLOW UP INFORMATION WAS RECEIVED BY GLOBAL PHARMACOVIGILANCE (GPV), FROM A NURSE, REGARDING THE EVENT. IN (B)(6) 2012, THE PATIENT WAS SWITCHED TO HEMODIALYSIS BEFORE THE ONSET OF PERITONITIS. THE NURSE CONFIRMED THAT THE PATIENT EXPERIENCED PERITONITIS BUT COULD NOT PROVIDE AN ONSET DATE. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH CEFIPIME IV. ON (B)(6) 2012, THE PATIENT'S PD CATHETER WAS REMOVED. PER THE NURSE, THE CAUSE OF THE PERITONITIS WAS TOUCH CONTAMINATION, WHICH HAD OCCURRED DURING DAILY FLUSHING, WHILE THE PATIENT WAS NOT UNDERGOING PD THERAPY. THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE PERITONITIS. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2012, THE PD CATHETER WAS REINSERTED AND THE PATIENT RESTARTED PD THERAPY ON (B)(6) 2012. PER THE NURSE, THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL THERAPY.

    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 67 YR Hospitalization| R DIANEAL PD4| HOMECHOICE