BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2022725 · Received March 17, 2011

    Report

    Report Number
    1423500-2011-03354
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    March 5, 2011
    Report Date
    March 6, 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 HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. HOWEVER, THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION AS OF YET. IF THE SAMPLE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A SYSTEM ERROR (SE) 2240 (AIR IN SET) OCCURRED DURING DWELL. A COMPANION SAMPLE WAS RECEIVED AND EVALUATED. THE SET WAS PLACED ON A MACHINE FOR PRIMING AND RUN WITH NO ALARMS NOTED. NO MANUFACTURING ABNORMALITIES WERE NOTED DURING VISUAL INSPECTION). THE COMPLAINT COULD NOT BE CONFIRMED IN THE LAB. THE ROOT CAUSE IS UNDETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    A CARE GIVER (CG) CONTACTED (B)(6) REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOME CHOICE (HC) UNIT DURING DWELL. THE CG STATED THAT THEY CLOSED ALL THE CLAMPS AND CYCLED THE POWER, AND GOT A SYSTEM ERROR 2367. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED IN CLEARING THE ALARM THEN EXPLAINED A SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP AND HAD THE HP END THERAPY AND RECOMMENDED THEY START OVER WITH NEW SUPPLIES. THE TSR REVIEWED PROPER PROCEDURES PER THE USER MANUAL WITH THE HP. THE PATIENT WAS INVOLVED, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. A FOLLOW UP WAS MADE VIA PHONE CALL. THE PATIENT STATED THE FOLLOWING: NOTHING WAS NOTICED WITH THE SUPPLIES AND USING NEW SUPPLIES CLEARED THE ALARM. THE SAMPLE WAS DISCARDED AND A COMPANION SAMPLE WAS AVAILABLE AND REQUESTED WITH LOT NUMBER H10L17040. 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 H10L17040

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR HOMECHOICE