BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP EXTD LIFE TRANS SET W/TWIST CLAMP EX SHORT

    MDR report key: 1133345 · Received August 22, 2008

    Report

    Report Number
    1423500-2008-00767
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    June 1, 2008
    Report Date
    July 30, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    PMA / PMN Number
    K842885A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS BEEN DISCARDED BY THE CUSTOMER; THEREFORE AN EVAL CANNOT BE PERFORMED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER FOR A LOW DRAIN VOLUME ALARM DURING THE INITIAL DRAIN CYCLE OF PERITONEAL DIALYSIS (PD) THERAPY THAT WAS RESOLVED WITH THE TECHNICAL SERVICE REPRESENTATIVE DURING INITIAL CONTACT. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. IN 2008, PRODUCT SURVEILLANCE CONTACTED THE PD NURSE WHO STATED THE PT WAS HOSPITALIZED FOR PERITONITIS. DURING A SECOND FOLLOW-UP CALL ON SIX DAYS LATER, TO OBTAIN MORE INFO CONCERNING THE PERITONITIS, THE NURSE STATED THAT THE PT WAS COMPLAINING OF ABDOMINAL PAIN AND WAS DIAGNOSED WITH PERITONITIS AND ADMITTED TO THE HOSPITAL FOR SIX DAYS FROM THE PREVIOUS MONTH. THE NURSE STATED THAT THE PERITONITIS WAS A RESULT OF THE PT DROPPING THE TRANSFER SET, PICKING IT UP, AND RE-USING IT. THE NURSE ALSO INDICATED THAT THE PT HAS BEEN TRAINED ON PROPER PROCEDURES SINCE THE INCIDENT. A CULTURE WAS TAKEN ON THAT MONTH, WITH NO BACTERIAL ORGANISM IDENTIFIED OR CLOUDY DIALYSATE. ANOTHER CULTURE WAS TAKEN ON THE FIRST DAY, SHOWING CLOUDY DIALYSATE AND IDENTIFIED ENTEROCOCCUS FAECEFIC AS THE BACTERIAL ORGANISM. LYMPHOCYTES WERE AT 6%. A THIRD CULTURE WAS TAKEN ON TWO DAYS LATER, AND NO BACTERIAL ORGANISM WAS IDENTIFIED. THE PT WAS GIVEN 1 GRAM OF VANCOMYCIN INTRAVENOUSLY FOR A WEEK FROM THE FIRST DAY. THE NURSE STATED THAT THE PT HAS RECOVERED FROM THE PERITONITIS EPISODES AS OF THE LAST DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTD LIFE TRANS SET W/TWIST CLAMP EX SHORT 78KDJ KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R