BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2870787 · Received December 12, 2012

    Report

    Report Number
    1416980-2012-07173
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    December 1, 2012
    Report Date
    December 6, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. THE PRODUCT CODE IS UNKNOWN, THEREFORE, 510K NUMBER IS UNKNOWN. THIS COMPLAINT FOR A REPORT OF USE ERROR - BREACH IN ASEPTIC TECHNIQUE IS CONFIRMED, BECAUSE IT WAS REPORTED THAT THERE WAS A BREACH IN ASEPTIC TECHNIQUE; HOWEVER, THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED, SINCE IT IS UNSURE WHY THE PATIENT HAD A BREACH IN ASEPTIC TECHNIQUE. A LABELING REVIEW FOUND THE LABELING TO BE ADEQUATE FOR THE PREVENTION OF THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. 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

    PRODUCT SURVEILLANCE CONTACTED THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) ON (B)(4) 2012 REGARDING AN UNRELATED EVENT AND THE FOLLOWING WAS REPORTED. ON (B)(6) 2012 THE HOMECHOICE PATIENT (HP) WAS DIAGNOSED WITH PERITONITIS. THE CAUSE OF THE PERITONITIS EVENT WAS UNKNOWN. THE HP WAS STARTED ON THE ANTIBIOTICS OF CEFAZOLIN AND CIPRO (2G, IP, WITH EACH LAST FILL). AS OF THE TIME OF THE INITIAL REPORT THE HP WAS NOT HOSPITALIZED FOR THE EVENT. ON (B)(6) 2012, A FOLLOW UP REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV). THE PDRN BELIEVED THAT THERE WAS A BREAK IN ASEPTIC TECHNIQUE, DESCRIBED AS SOMETHING HAPPENED WHEN THE PATIENT DISCONNECTED FROM THE MACHINE, AND THAT THE PERITONITIS EVENT WAS NOT RELATED TO BAXTER PRODUCTS. ASEPTIC TECHNIQUE WAS REVIEWED WITH THE PATIENT. THE HP'S PD THERAPY IS ONGOING AND THE HP IS RECOVERING FROM THIS PERITONITIS EVENT.

    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 Required Intervention L5B9771 DIANEAL LOW CAL 2.5% DEX 6L/6L| L5B9727 DIANEAL LOW CA 2.5% 2L/3L| L5B4825 DIANEAL LOW CAL 1.5% DEX 2L/2| L5B9770 DIANEAL LOW CA 1.5% DEX 6L/6L