BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOMECHOICE INTEGRATED PD SET W/CASSETTE 3-PRONG

    MDR report key: 3008640 · Received June 8, 2007

    Report

    Report Number
    1423500-2007-00203
    Event Type
    Other
    Date Received
    June 8, 2007
    Date of Event
    May 19, 2007
    Report Date
    May 19, 2007
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4. THE SAMPLE WAS DISCARDED AND IS UNAVAILABLE FOR ANALYSIS. THERE ARE NO FURTHER MEASURES TO BE TAKEN RELATIVE TO THIS MATTER. RENAL PRODUCT SURVEILLANCE, QUALITY ENGINEERING, AND PLANT MANUFACTURING WILL CONTINUE TO MONITOR THIS PRODUCT LINE AND TAKE CORRECTIVE/PREVENTATIVE ACTION AS APPROPRIATE. HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT ((B)(6) 2007), CAPD TRANSFER SET ((B)(6) 2007), LOW CALCIUM DIANEAL SOLUTION STRENGTH UNKNOWN ((B)(6) 2007).

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED THE BAXTER TECHNICAL SERVICES CENTER FOR ASSISTANCE IN ENDING THERAPY. THE HP WAS IN DRAIN 6 OF 6 AND CUT THE PATIENT LINE BECAUSE IT WAS TANGLED, AND SHE THOUGHT THERAPY WAS COMPLETE. THE TECHNICAL SERVICES REPRESENTATIVE (TSR) ASSISTED THE HP WITH ENDING THERAPY. THE HP STILL NEEDED TO DRAIN BUT DID NOT HAVE ANY MANUAL SUPPLIES. THE HP WAS REFERRED TO HER RN BY THE TSR FOR FURTHER INSTRUCTIONS. PER THE HP'S RN, THE HP CAME TO THE DIALYSIS CENTER THE NEXT DAY BE DRAINED. THE RN WAS NOT AWARE THAT THE HP HAD CUT THE PATIENT LINE. THE RN AGREED TO RETAIN THE HP TO NOT CUT THE PATIENT LINE DURING THERAPY. THE RN ALSO STATED THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE INTEGRATED PD SET W/CASSETTE 3-PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR