BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1792073 · Received August 10, 2010

    Report

    Report Number
    1423500-2010-02318
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 12, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE NOT AVAILABLE AS PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOMECHOICE PATIENT (HP) WHO REQUESTED TECHNICAL ASSISTANCE ON (B)(6) 2010. HP REQUESTED ASSISTANCE IN ENDING THERAPY IN ORDER TO GO TO THE HOSPITAL. THIS WAS DURING PATIENT USE. TECHNICAL SERVICE REPRESENTATIVE WAS ABLE TO ASSIST HP WITH A SOLUTION OVER THE PHONE. ON (B)(6) 2010 PRODUCT SURVEILLANCE CONTACTED THE PERITONEAL DIALYSIS (PD) NURSE REGARDING HOME PATIENT GOING TO THE HOSPITAL. THE NURSE STATED THAT THE PATIENT HAD PERITONITIS. SHE STATED SHE DID NOT KNOW THE CAUSE OF THE PERITONITIS AND WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION. THIS IS COMPLAINT ONE OF FOUR RELATED COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4), DIANEAL LOW CAL, SINGLE BAG DEXTROSE 1.50%