BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2183492 · Received July 29, 2011

    Report

    Report Number
    1423500-2011-09964
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 20, 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). THIS COMPLAINT FOR A SYSTEM ERROR 2240 ALARM (AIR IN SET) DURING DWELL WAS CONFIRMED DUE TO AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THE CONNECTION BETWEEN THE PATIENT LINE AND THE TRANSFER SET WAS NOT TIGHT. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND THE BATCH REVIEW WILL NOT BE PERFORMED. THIS REVIEW FINDS THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR(S) IN THE COMPLAINT. THE CAUSE WAS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    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.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN THE SET), DURING DWELL ON THE HOME CHOICE (HC). THE TSR EXPLAINED THE ALARM AND ASSISTED THE HP TO CYCLE THE POWER OFF/ON TWICE TO CLEAR THE ALARM, THEN START OVER WITH NEW SUPPLIES. THE HP STATED HE WOULD DO A MANUAL DRAIN. PRODUCT SURVEILLANCE CONTACTED THE HP ON (B)(6) 2011 REGARDING THE SYSTEM ERROR 2240 ALARM. PER THE HP, THERE WAS A DRIP AT THE LUER CONNECTION THAT CAUSED THE ALARM. THE HP STATED HE DID NOT TIGHTEN THE CONNECTION GOOD ENOUGH. PRODUCT SURVEILLANCE ASKED THE HP IF HE FOLLOWED UP WITH HIS PD RN REGARDING THE ALARM AND DID NOT FOLLOW UP WITH HIS PD RN. 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 74 YR HOMECHOICE