BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2192009 · Received August 4, 2011

    Report

    Report Number
    1423500-2011-10277
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 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 LOW DRAIN VOLUME ALARM WAS NOT CONFIRMED. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE REPORT WAS AIR IN PATIENT LINE; HOWEVER, THE REPORT OF AIR IN LINE WAS NOT CONFIRMED AND A CAUSE OF THE AIR 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 RENQ-CAPA-(B)(4).

    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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A LOW DRAIN VOLUME ALARM, WHICH OCCURRED ON THE HOMECHOICE DURING USE DURING INITIAL DRAIN. THE PATIENT WAS CONNECTED. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE PATIENT PERFORM MULTIPLE TROUBLESHOOTING STEPS. THE PATIENT NOTED A LARGE AMOUNT OF AIR IN THE PATIENT LINE. THE TSR INSTRUCTED THE PATIENT TO START OVER WITH NEW SUPPLIES AND CALL BACK TO TROUBLESHOOT FURTHER IF THE LOW DRAIN VOLUME ALARM REOCCURRED. 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 LOW DRAIN VOLUME ALARM. THE PATIENT STATED THEY DID NOT KNOW HOW AIR MIGHT HAVE GOT INTO THE LINE BUT STATED WHEN THEY WERE GETTING READY TO START OVER, THE FLUID RUSHED OUT OF THE DRAIN LINE SO THE PATIENT CONTINUED THERAPY. THE PATIENT STATED THEY DID NOT REMEMBER IF THEY SPOKE TO THEIR NURSE ABOUT THE ALARM BECAUSE THEY WERE TRAVELLING WHEN IT OCCURRED. BAXTER PRODUCT SURVEILLANCE RECOMMENDED CONTACTING THE NURSE WHEN AIR IS OBSERVED IN THE LINE. THE PATIENT STATED THEY HAVE 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 82 YR HOMECHOICE