BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET

    MDR report key: 3250667 · Received July 26, 2013

    Report

    Report Number
    1416980-2013-19930
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    June 6, 2013
    Report Date
    July 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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. A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13D19031, H13C06048, AND H13B26089 AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 3 OF 3 INVOLVED IN THIS EVENT. THIS IS A REPORT OF A PATIENT WHO EXPERIENCED PERITONITIS COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS. THERAPY WAS REINITIATED. IT WAS REPORTED THAT THE CAUSE OF THE PERITONITIS WAS DUE TO THE PATIENT HAVING SOLUTION DWELLING IN THEIR PERITONEUM FOR A WEEK AS A RESULT OF A BOWEL OBSTRUCTION. THE PATIENT WAS IN THE HOSPITAL FOR THE BOWEL OBSTRUCTION PRIOR TO THE DIAGNOSIS OF PERITONITIS. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS FOR THE EVENT. THE PATIENT RECOVERED FROM THE EVENT AND WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350367 EXTENSION SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention HOMECHOICE, DIANEAL PD4 AMBUFLEX| ANTI-DIABETIC MEDICATION, MINICAP,| HOMECHOICE AUTOMATED PD SET WITH CASSETTE,