BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET

    MDR report key: 2933670 · Received January 29, 2013

    Report

    Report Number
    1416980-2013-02179
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    November 1, 2012
    Report Date
    January 8, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K833065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 3 OF 4. THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR ASSOCIATED LOT NUMBERS H12I05014 AND H12G31055 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF RELEVANT ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION WAS NOT CONFIRMED AND THE CAUSE WAS NOT IDENTIFIED BECAUSE NO SAMPLE WAS RETURNED TO BAXTER, THE REVIEW OF MANUFACTURING RECORDS FOR POTENTIALLY ASSOCIATED LOTS REVEALED NO ISSUES OR DEVIATIONS FROM STANDARD PROCEDURE, AND THE USER DID NOT DESCRIBE ANY TYPES OF USE ERRORS OR OTHER DEVICE MALFUNCTIONS THAT MIGHT HAVE CAUSED THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT FROM A CONSUMER OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2013, THE PATIENT'S MOTHER CONTACTED BAXTER CUSTOMER SERVICES AND REPORTED THE FOLLOWING INFORMATION. ON (B)(6) 2012, THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNREPORTED DATE, PD THERAPY WAS WITHDRAWN. ON AN UNREPORTED DATE, THE PATIENT WAS COMPLAINING ABOUT BEING UNCOMFORTABLE FOR A WEEK. ON AN UNREPORTED DATE IN (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED FOR THE EVENT. THE CONSUMER REPORTED THE CAUSE OF THE PERITONITIS WAS RELATED TO THE MACHINE MOVING THE PATIENT'S CATHETER OUT OF PLACE, LEAVING IT SIDEWAYS. THEN, FOLLOWING A BIG MEAL, AN INFECTION OCCURRED DUE TO THE CATHETER NOT BEING IN PLACE. TREATMENT WAS NOT REPORTED. ON AN UNKNOWN DATE IN (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT RECOVERED FROM THE EVENT. THE FOLLOWING ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE NURSE. PHONE ATTEMPTS WERE MADE (B)(4) 2013. A WRITTEN REQUEST FOR ADDITIONAL INFORMATION WAS MAILED TO THE NURSE ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39039 EXTENSION SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization DIANEAL PD4 AMBUFLEX 2.5%| DIANEAL PD4 AMBUFLEX 1.5%| HOMECHOICE