BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2233875 · Received September 6, 2011

    Report

    Report Number
    1423500-2011-11692
    Event Type
    Malfunction
    Date Received
    September 6, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN AT THIS TIME; THEREFORE, A BATCH REVIEW WILL NOT BE CONDUCTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A CONNECTION ISSUE IS CONFIRMED BECAUSE THE PATIENT STATED THAT SHE DID NOT TIGHTEN THE BAG TIGHT ENOUGH AND THAT'S WHY IT DISCONNECTED. PATIENTS ARE ADVISED TO CHECK THAT ALL CONNECTIONS ARE SECURE BEFORE BEGINNING THERAPY. THIS REVIEW FINDS THE LABELING ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A SUPPLY BAG THAT BECAME DISCONNECTED AND THE HOME PATIENT (HP) NEEDED ASSISTANCE ENDING THERAPY IN DWELL 6 OF 6 ON THE HOMECHOICE MACHINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP END THERAPY. PRODUCT SURVEILLANCE CONTACTED THE HP ON (B)(4) 2011 REGARDING THE DISCONNECTION OF THE SOLUTION BAG. THE HP STATED THAT SHE DID NOT TIGHTEN THE BAG TIGHT ENOUGH AND THAT?S WHY IT DISCONNECTED. THE HP DID NOT SET UP WITH NEW SUPPLIES, BUT STATED SHE HAD RESUMED THERAPY ON THE CYCLER WITHOUT PROBLEMS THE FOLLOWING DAY. THE HP STATED SHE FOLLOWED UP WITH HER PERITONEAL DIALYSIS NURSE REGARDING THE DISCONNECTION. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR HOMECHOICE