BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2200811 · Received August 11, 2011

    Report

    Report Number
    1423500-2011-10547
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 24, 2011
    Report Date
    July 24, 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). PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR A SYSTEM ERROR 2267 (FLUID AND AIR IN SET) WAS NOT CONFIRMED DUE TO LACK OF A 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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2267 (AIR AND FLUID IN SET), WHICH OCCURRED ON THE HOMECHOICE DURING USE DURING DWELL. THE PATIENT WAS CONNECTED. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE PATIENT CYCLE THE POWER AND A SE 2367 OCCURRED. THE TSR HAD THE PATIENT CYCLE THE POWER AGAIN TO THE "PRESS GO TO START" PROMPT. THE TSR HAD THE PATIENT DISCONNECT, REMOVE THE CASSETTE, AND DISCARD THE SUPPLIES. THE TSR EXPLAINED THE ALARM, REVIEWED PROPER PROCEDURES PER THE USER MANUAL, AND ADVISED THE PATIENT TO CONTACT THEIR NURSE. 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 CAREGIVER (CG) ON (B)(6) 2011 REGARDING THE REPORTED SE 2267. THE CG STATED THERE WAS NO VISIBLE DAMAGE OR ABNORMALITIES NOTICED WITH THE SUPPLIES IN USE AND THEY DID NOT KNOW HOW AIR MIGHT HAVE GOT INTO THE SET. THE PATIENT DID NOT COMPLETE THERAPY THAT NIGHT BUT WAS ABLE TO RESUME THERAPY SUCCESSFULLY WITH NEW SUPPLIES. THE CG STATED THE PATIENT DID SPEAK WITH THE NURSE ABOUT THE ALARM. THE PATIENT HAS BEEN CONTINUING THERAPY ON THE CYCLER SUCCESSFULLY. 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 56 YR HOMECHOICE