BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET

    MDR report key: 2062950 · Received April 19, 2011

    Report

    Report Number
    1423500-2011-04703
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 28, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K833065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 3 OF 4 FOR THIS INCIDENCE OF PERITONITIS. AS PATIENT DISCARDS SUPPLIES AFTER EACH USE, A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. FOLLOW UP WILL BE SUBMITTED AS INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4).THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS WAS UNDETERMINED. A BATCH REVIEW OF THE POTENTIALLY ASSOCIATED LOT NUMBER (H10J13043) REVEALED NO EXCEPTIONS DURING THE MANUFACTURING PROCESS. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    INFORMATION WAS OBTAINED FROM THE PERITONEAL DIALYSIS (PD) NURSE ON (B)(6) 2011 DURING A FOLLOW UP BY (B)(6) FOR AN UNRELATED COMPLAINT. THE NURSE INDICATED THE PATIENT HAD PERITONITIS. SHE REPORTED THAT ON AN UNKNOWN DATE THE PATIENT BEGAN PERITONEAL DIALYSIS USING LOCAL PD4 AMBUFLEX, IP. ON (B)(6) 2011 THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THERE WAS NO EXIT SITE OR TUNNEL INFECTION. TREATMENT INCLUDED ANTIBIOTIC THERAPY. THE NURSE STATED THE EVENT OF PERITONITIS WAS RELATED A RIGHT FOOT INFECTION. ON AN UNREPORTED DATE THE PD NURSE REVIEWED WITH THE PATIENT HOW TO PERFORM PD THERAPY USING ASEPTIC TECHNIQUE. THE PATIENT WAS HOSPITALIZED FOR 8 DAYS (DATES UNKNOWN). IN (B)(6) 2011, THE EVENT OF RIGHT FOOT INFECTION AND PERITONITIS WERE CONSIDERED RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R DIANEAL LOW CAL (PD4) AMBUFLEX| HOMECHOICE