BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3073557 · Received April 23, 2013

    Report

    Report Number
    1416980-2013-10170
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 9, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR USE ERROR - BREACH IN ASEPTIC TECHNIQUE IS CONFIRMED BECAUSE THE INFORMATION REPORTED THAT THE PATIENT EXTENSION LINE WAS DISCONNECTED AND THEN WAS RECONNECTED, WHICH IS A BREACH IN ASEPTIC TECHNIQUE. PER THE PATIENT AT-HOME GUIDE, USERS ARE INSTRUCTED TO FOLLOW ASEPTIC TECHNIQUE TAUGHT BY DIALYSIS CENTER WHEN HANDLING LINES WHEN PERITONEAL DIALYSIS THERAPY. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CARE GIVER (CG) REPORTED THAT A HOME PATIENT (HP) WAS DISORIENTED AND FOR A SHORT TIME DISCONNECTED THE PATIENT LINE EXTENSION AND THEN RECONNECTED DURING DWELL 3 OF 4 ON THE HOMECHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE CAREGIVER (CG) TO END THERAPY AND START OVER WITH NEW SUPPLIES OR FINISH WITH MANUALS. THE TSR ALSO ADVISED THE CG TO CONTACT THE REGISTERED NURSE (RN) ABOUT POSSIBLE EXPOSURE TO UNSTERILE AIR EVEN THOUGH NO ALARMS OCCURRED. NO SAMPLES ARE AVAILABLE FOR EVALUATION. THE HC WAS OPERATIONAL. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173440 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 78 HOMECHOICE