BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP DISCONNECT CAP

    MDR report key: 1961151 · Received January 14, 2011

    Report

    Report Number
    1423500-2011-00604
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 20, 2010
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBERS FOR THIS PRODUCT WERE INITIALLY REPORTED AS UNKNOWN. HOWEVER, 3 POTENTIALLY ASSOCIATED LOT NUMBERS HAVE BEEN DISCOVERED, AND A BATCH REVIEW WAS CONDUCTED ON: 10I16H25, 10H23H25 AND 19G15H25 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. ROOT CAUSE OF THIS PERITONITIS WAS DETERMINED AS POOR ASEPTIC TECHNIQUE. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USER ERROR IDENTIFIED IN THIS INCIDENT. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THIS IS THE THIRD OF THREE REPORTS ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED THEREFORE NO EVALUATION WAS PERFORMED. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW COULD NOT BE CONDUCTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS IS REPORT 3 OF 3 ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING WITH THE TECHNICAL SERVICE REPRESENTATIVE (TSR) FOR A SEPARATE ISSUE, THE PATIENT REPORTED SHE HAD BEEN DISCHARGED FROM THE HOSPITAL AFTER BEING TREATED FOR PERITONITIS. ON (B)(6) 2011 THE FACILITY NURSE PROVIDED THE FOLLOWING INFORMATION: THE PATIENT WAS HOSPITALIZED ON (B)(6) 2010 WITH A DIAGNOSIS OF PERITONITIS. THERE WAS NO EXIT SITE OR TUNNEL INFECTION. THE PATIENT WAS TREATED WITH VANCOMYCIN, LOADING DOSE OF 2 GRAMS, INTRAPERITONEAL (IP) AND A MAINTENANCE DOSE OF 30MG PER LITER. THE PATIENT ALSO RECEIVED THREE ADDITIONAL LOADING DOSES OF 3 GRAMS AFTER DISCHARGE FROM THE HOSPITAL ON (B)(6) 2010. THERAPY CONTINUED THROUGHOUT THE EVENT. THE CAUSE OF THE PERITONITIS WAS LIKELY A BREAK IN ASEPTIC TECHNIQUE AS THE PATIENT HAD BECOME COMPLACENT ABOUT TECHNIQUE. THE PATIENT HAS BEEN RETRAINED. THE PATIENT HAS RECOVERED FROM THIS EVENT. THE NURSE DID NOT FEEL THE PERITONITIS WAS RELATED TO THE BAXTER SOLUTIONS OR DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXICAP DISCONNECT CAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R (B)(4) 1.5% LO/CAL 6L/6L DNL| (B)(4) 2.5% LO/CAL 6L| HOMECHOICE CYCLER