BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1950043 · Received January 6, 2011

    Report

    Report Number
    1423500-2011-00172
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 15, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. 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 WILL NOT BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A PHYSICIAN FROM (B)(6) OF PERITONITIS AND EXTRANEAL BAG WHICH RIPPED IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, DURING CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD), THE PATIENT'S EXTRANEAL BAG RIPPED, AND THE DIALYSIS WAS PERFORMED AS MANUAL. ON (B)(6) 2010, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO PERITONITIS. THE PHYSICIAN STATED THAT THE PATIENT FEELS SIGNIFICANTLY BETTER AND HIS TREATMENT WITH ANTIBIOTICS HAS BEEN ADJUSTED PROPERLY. THE PHYSICIAN ESTIMATED A 90% IMPROVEMENT IN THE PATIENT'S STATE, THEREFORE THE EVENT OF PERITONITIS WAS RESOLVING. THE OUTCOME OF EXTRANEAL BAG RIPPED WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT REMAINED HOSPITALIZED. THE ACTION TAKEN WITH EXTRANEAL THERAPY WAS UNKNOWN. THE REPORTING PHYSICIAN'S ASSESSMENT OF CAUSALITY FOR THE EVENT OF PERITONITIS WAS UNCLASSIFIED, HOWEVER THE PHYSICIAN SUSPECTED THAT THE INCIDENT OF THE EXTRANEAL BAG BEING RIPPED COULD HAVE CONTRIBUTED TO THE PERITONITIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R EXTRANEAL VIAFLEX