BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2726875 · Received September 5, 2012

    Report

    Report Number
    1423500-2012-17312
    Event Type
    Malfunction
    Date Received
    September 5, 2012
    Date of Event
    August 16, 2012
    Report Date
    August 16, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. THE PROBLEM WAS CONFIRMED AND THE CAUSE WAS UNDETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REGARDING A CHECK SUPPLY LINE ALARM THAT APPEARED ON THE HOME CHOICE (HC) DURING PRIMING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) PULL UP AND DOWN ON THE LINES NEAR THE DOOR, FLIP THE SUPPLY BAG OVER, SLIDE THE SUPPLY LINE CLAMP DOWN LINE, AND APPLY PRESSURE TO SUPPLY BAG. THE FRANGIBLE WAS BROKEN AND SEPARATED. THE ALARM REPEATED. THE TSR HAD THE HP CHECK THE LUMEN AND PER THE HP WAS BLOCKED. THE TSR ADVISED THE HP WOULD NEED TO START OVER WITH ALL NEW SUPPLIES SINCE THE HP DID NOT HAVE AN EXTRA SUPPLY LINE. THE HP STARTED THEY WOULD CHANGE OUT THE BAG. THE TSR EXPLAINED THAT THE HP NEEDED TO CHANGE OUT ALL OF THE SUPPLIES. THE HP STATED SHE KNEW BUT WAS TIRED AND THAT WAS HOW SHE DOES IT. THE HP STATED THAT THE NURSE HAD ADVISED TO CHANGE EVERYTHING OUT WHEN STARTING OVER BUT THE HP STATED SHE CAPS THE LINE AND DOES IT QUICKLY. THE TSR ADVISED THE HP WOULD NEED TO START OVER WITH NEW SUPPLIES OR RISK INFECTION. THE TSR ADVISED TO START OVER WITH NEW SUPPLIES. THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED. BAXTER WAS CONTACTED BY THE PATIENT ON (B)(6) 2012. THE PATIENT STATED THE FOLLOWING: THERAPY HAD BEEN GOING FINE SINCE THE EVENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION 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 44 YR HOME CHOICE