BEUDAMED
    FDA Adverse Event Injury Summary report: N

    U1208 ULTRA SET CAPDDISCONNECT DISPOSABLE Y SET

    MDR report key: 1831363 · Received September 10, 2010

    Report

    Report Number
    1423500-2010-03344
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 20, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K961825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR SUSPECT LOT NUMBER (H10B26074), WITH NO DEFECTS NOTED. THE ASSIGNABLE CAUSE OF THE REPORTED PROBLEM OF PERITONITIS WAS USE ERROR - POOR ASEPTIC TECHNIQUE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR(S) IN THIS COMPLAINT. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4).AS THE PATIENT'S DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. THIS IS NUMBER 4 OF 4 COMPLAINTS REPORTED FOR THIS PERITONITIS.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HE WAS CURRENTLY GETTING OVER A CASE OF PERITONITIS. THE NURSE CLARIFIED THAT THIS WAS A RECURRING PERITONITIS. PER THE NURSE, THE SUSPECTED CAUSE IS TOUCH CONTAMINATION AND THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE. DUE TO THE PATIENT BEING TRANSFERRED TO IN-CENTER HEMODIALYSIS, LIMITED INFORMATION REGARDING THE REPORTED PERITONITIS WAS AVAILABLE. DURING THE WEEK OF (B)(6), 2010, THE PATIENT PRESENTED WITH CLOUDY EFFLUENT AND ABDOMINAL PAIN AND WAS HOSPITALIZED FOR THE RECURRING PERITONITIS. THE PATIENT'S CATHETER WAS REMOVED AND HE STARTED IN CENTER HEMODIALYSIS ON (B)(6), 2010. THE PATIENT WAS TREATED WITH ANTIBIOTIC (UNKNOWN) AND RECOVERED FROM THE PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U1208 ULTRA SET CAPDDISCONNECT DISPOSABLE Y SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R