BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1955441 · Received January 10, 2011

    Report

    Report Number
    1423500-2011-00385
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 17, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT (GD878223) AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THOSE LOTS. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE ROOT CAUSE OF THIS INCIDENT IS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE PATIENTS ARE INSTRUCTED TO DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A US FACILITY NURSE REPORTED A PATIENT EXPERIENCING PERITONITIS IN A (B)(6) MALE COINCIDENT WITH DIANEAL PD4 ULTRABAG THERAPY. THE PATIENT REPORTEDLY EXPERIENCED CONSTIPATION ALSO. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 ULTRABAG (DOSE, FREQUENCY, LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE PATIENT'S NURSE REPORTED THE FOLLOWING INFORMATION. ON AN UNREPORTED DATE, THE PATIENT MADE A MISTAKE AND EXPERIENCED TOUCH CONTAMINATION AND CONSTIPATION. ON (B)(6) 2010, THE PATIENT DEVELOPED AND WAS HOSPITALIZED FOR PERITONITIS. WHILE HOSPITALIZED, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED WITH UNKNOWN RESULTS. IT WAS UNREPORTED IF TREATMENT WAS PROVIDED. ON AN UNREPORTED DATE, DIANEAL THERAPY WAS WITHDRAWN. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND RECOVERING FROM THE PERITONITIS. IT WAS UNREPORTED IF THE PATIENT RECOVERED FROM THE MISTAKE/ TOUCH CONTAMINATION AND CONSTIPATION. THIS IS THE MASTER COMPLAINT FOR THE EVENT OF PERITONITIS.

    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 64 YR Hospitalization| R 1.5%, 2.5% AND 4.25% 2.5L/3L ULTRABAGS