BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1961150 · Received January 14, 2011

    Report

    Report Number
    1423500-2011-00603
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 20, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    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 2 OF 3 ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBERS FOR THIS PRODUCT WERE INITIALLY REPORTED AS UNKNOWN. HOWEVER, 2 POTENTIALLY ASSOCIATED LOT NUMBERS HAVE BEEN DISCOVERED, AND A BATCH REVIEW WAS CONDUCTED ON LOTS: GD879171 AND GD879163 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. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THIS IS THE SECOND OF THREE REPORTS 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)(4) 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 MINI-CAP, DISCONNECT W/PVP-1SOLUTION DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    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