BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2071524 · Received April 28, 2011

    Report

    Report Number
    1423500-2011-05115
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 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). THIS REPORT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED; HOWEVER, PER THE COMPLAINT INFORMATION THE CAUSE OF THE ALARM IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE CAUSED BY THE PATIENT NOT CONNECTED WHEN THERAPY INITIATED. 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. LABELING REVIEW FINDS THE LABELING ADEQUATE FOR THE USER ERROR IDENTIFIED IN THE COMPLAINT. 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). DURING INVESTIGATION BY BAXTER THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE, A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REPORTED RECEIVING SYSTEM ERROR 2240 (AIR IN LINE) ALARM ON THE HOMECHOICE (HC) MACHINE DURING THE INITIAL DRAIN. THE PATIENT STATED THEY JUST REALIZED THEY CONNECTED TO THE HC DURING THE INITIAL DRAIN AND RECEIVED THE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) AND EXPLAINED THE ALARM. THE TSR ADVISED THE HP TO START OVER WITH NEW SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(4) 2011. THE NURSE STATED THAT THE PATIENT HAD NOT CONTACTED THE CLINIC REGARDING THE EVENT, HOWEVER, THEY WOULD FOLLOW UP WITH THE PATIENT. THEY HAD HEARD FROM THE PATIENT THIS MORNING AND THE PATIENT WAS DOING FINE WITH THERAPY. PRODUCT SURVEILLANCE CONTACTED THE PATIENT ON (B)(4)2011. THE PATIENT VERIFIED THAT THERE WERE NO HOLES, LEAKS, OR DEFECTS IN THE SUPPLIES. THE PATIENT STATED THAT HE DISCARDED SUPPLIES AND STARTED OVER WITH NEW ONES. THERE HAVE BEEN NO ISSUES SINCE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    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 38 YR HOMECHOICE