BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1970544 · Received January 25, 2011

    Report

    Report Number
    1423500-2011-00998
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 25, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 3 OF 3 OF THIS REPORTABLE EVENT. AS PATIENTS DISCARD 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). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER H10G26065 WITH NO DEFECTS NOTED. THE ASSIGNABLE CAUSE IS USE ERROR-POOR AESEPTIC TECHNIQUE. THE CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO THE PREVENTION OF USE ERROR IN ASEPTIC TECHNIQUE. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    DURING AN UNRELATED ALARM COMPLAINT ON (B)(6) 2010 THE PATIENT REPORTED THAT THEY HAD AN INFECTION. DURING A FOLLOW UP CALL REGARDING THIS INFECTION ON (B)(4) 2010, THE PDRN REPORTED THAT THE PATIENT WAS DIAGNOSED WITH PERITONITIS ON (B)(6) 2010. SHE REPORTED THAT THE PATIENT PRESENTED WITH ABDOMINAL PAIN ON (B)(6) 2010 AND PD EFFLUENT CULTURES AND BLOOD WORK WERE DONE AT THAT TIME. THE PATIENT WAS THEN STARTED ON IP ANTIBIOTICS (CEFAZOLIN AND FORTAZ). ON THAT DATE, THE PATIENT COMPLAINED OF INCREASED ABDOMINAL PAIN AND WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2010 FOR THIS PERITONITIS AND ANTIBIOTIC THERAPY WAS CHANGED TO VANCOMYCIN AND FORTAZ IP. THE PATIENT WILL COMPLETE ANTIBIOTIC THERAPY ON (B)(6) 2010. THE NURSE STATES THAT THE INFECTION COULD HAVE BEEN CAUSED BY TOUCH CONTAMINATION OR THE HEATING VENT ON THE HC MAY HAVE TURNED ON AND BLEW ON THE PATIENT'S CATHETER DURING SET UP, BUT SHE COULD NOT SAY FOR SURE. THERE WAS NO ALLEGATION AGAINST ANY BAXTER PRODUCT. THE PATIENT CONTINUES PD THERAPY WITHOUT DIFFICULTY. THE PDRN REPORTS THAT THE PERITONITIS IS RESOLVING AS THE PATIENT HAS REPORTED DECREASED ABDOMINAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R HOME CHOICE CYCLER| DIANEAL LOW CA 1.5 6L/6L DIANEAL LOW CA 2.5 6L/6L