BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2221655 · Received August 24, 2011

    Report

    Report Number
    1423500-2011-11182
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 31, 2011
    Report Date
    July 31, 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). 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. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A USE ERROR - FAILED TO FOLLOW THERAPY STEPS WAS CONFIRMED. THE ROOT CAUSE WAS USE ERROR; PER THE COMPLAINT INFORMATION, THE CAUSE WAS THE HP LEFT THE PATIENT LINE CLAMP CLOSED DURING PRIME AND NOTICED THAT THERE WAS AIR IN THE LINE BUT CONNECTED AND STARTED THERAPY ANYWAY. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH (B)(4).

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING OF AN AIR IN LINE ISSUE WHILE ON THE HOMECHOICE (HC) DURING DWELL 1, THE HOME PATIENT (HP) REVEALED THAT SHE HAD LEFT THE PATIENT LINE CLAMP CLOSED DURING PRIME, BUT CONNECTED AND STARTED THERAPY ANYWAY DESPITE NOTICING THE AIR IN THE LINE. THE HC WAS THEN IN DWELL 1 AND THE HP SAID ALL THE AIR WENT INTO HER AND THEN HER SHOULDER BLADES WERE SORE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO NOTIFY THE NURSE AS SOON AS POSSIBLE FOR FURTHER INSTRUCTIONS. THE TSR HAD THE HP CHECK THE LINE FOR AIR AND THEY FOUND NONE. THIS MEANT IT WAS MOST LIKELY INSIDE THE HP. THE HP AGREED CALL THE NURSE. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW UP WITH THE NURSE, IT WAS REVEALED THAT THE HP CONTACTED THEM ABOUT THIS EVENT. THE NURSE STATED THE HP UNDERSTANDS THAT IT WAS NOT CORRECT PROCEDURE TO CONNECT TO THE LINE WHEN THERE IS AIR IN IT. THE NURSE STATED THE HP IS DOING FINE AND HAD NO INJURY OR MEDICAL INTERVENTION FROM 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 50 YR HOMECHOICE