BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE 4 PRONG

    MDR report key: 1100885 · Received August 6, 2008

    Report

    Report Number
    1423500-2008-00720
    Event Type
    Injury
    Date Received
    August 6, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 23, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ON 6-19-2008, A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOME CHOICE (HC) DISPLAY DURING INITIAL DRAIN. THE HOME PATIENT (HP) AND BAGS WERE CONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED AND CLEARED THE ALARM. THE HP WAS TO START OVER USING NEW SUPPLIES AND WAS TO LET THE NURSE KNOW OF THE AIR IN THE LINE ALARM. THE CASSETTE WAS NOT AVAILABLE FOR EVAL. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.IN 2008, DURING A FOLLOW UP WITH THE HP'S NURSE, IT WAS MENTIONED THAT THE HP DEVELOPED PERITONITIS IN THE SAME MONTH, AND WAS ADMITTED TO THE HOSP. THE HP HAD ABDOMINAL PAIN AND CLOUD EFFLUENT. THE HP HAD THE CATHETER PULLED AND IS CURRENTLY ON HEMODIALYSIS. THE CULTURE TAKEN CAME BACK GRAM NEGATIVE BACILLI AND RARE YEAST. THE NURSE DID NOT HAVE ANY RECORDS OF WHAT ANTIBIOTICS WERE GIVEN AS THE HP WENT DIRECTLY TO HEMODIALYSIS FROM THE HOSP. REPORTEDLY, THE HP HAS SINCE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE 4 PRONG 78FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R