BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2141842 · Received June 27, 2011

    Report

    Report Number
    1423500-2011-08418
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 5, 2011
    Report Date
    June 5, 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 DUE TO A LACK OF SAMPLE. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE REPORT WAS NOT DETERMINED. 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 DEVICE WAS NOT AVAILABLE FOR EVALUATION AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, BAXTER CANNOT DETERMINE THE ROOT CAUSE AND A BATCH REVIEW WILL NOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 2. THE PATIENT WAS CONNECTED. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE PATIENT CYCLE THE POWER AND THE HC ALARMED SE 2367. THE TSR ADVISED THE PATIENT TO DISCONNECT. THE PATIENT WOULD COMPLETE THERAPY USING MANUAL SUPPLIES IN THE MORNING. THE TSR ADVISED THE PATIENT TO CONTACT THEIR REGISTERED NURSE (RN) IN THE MORNING. THE TSR REVIEWED PROPER PROCEDURE PER THE USER MANUAL WITH THE PATIENT. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE PATIENT ON (B)(6) 2011 REGARDING THE REPORTED SE 2240. THE PATIENT STATED THEY DID NOT NOTICE ANY VISIBLE DAMAGE OR ABNORMALITIES WITH THE SUPPLIES IN USE AND DID NOT KNOW HOW AIR GOT INTO THE LINES. THE PATIENT STATED THE SAMPLE WAS DISCARDED AND THEY DID NOT KNOW THE LOT NUMBER OF THE SUPPLIES. THE PATIENT STATED THEY DID NOT SPEAK WITH THEIR RN. BAXTER PRODUCT SURVEILLANCE INFORMED THE PATIENT THAT THEY SHOULD NOTIFY THEIR RN ABOUT THE SE 2240. 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 68 YR HOMECHOICE