BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2121176 · Received June 13, 2011

    Report

    Report Number
    1423500-2011-07508
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR CHECK PATIENT LINE ALARM WAS NOT CONFIRMED. THE REPORTED AIR BUBBLES FOUND IN THE PATIENT LINE DID NOT CAUSE THE CHECK PATIENT LINE ALARM. THE CAUSE FOR AIR IN LINE IS UNDETERMINED. THE CAUSE FOR CHECK PATIENT LINE ALARM WAS CLOSED CLAMP ON A PATIENT LINE. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. 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

    THIS REPORT IS FOR AIR IN THE PATIENT LINE. THE CUSTOMER CONTACTED BAXTER'S (B)(4) TO REPORT A CHECK PATIENT LINE WHICH OCCURRED ON HOME CHOICE (HC) DURING INITIAL DRAIN. THE BAXTER TECHNICAL REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) WITH TROUBLESHOOTING. THE HP STATED THAT THERE WAS AIR IN PATIENT LINE. THE TSR ADVISED TO START OVER WITH NEW SUPPLIES AND ASSISTED THE HP TO END THERAPY. THE HP WILL START OVER WITH NEW SUPPLIES. THE HC WAS OPERATIONAL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THIS WRITER CONTACTED HOME PATIENT (HP) ON (B)(6) 2011 REGARDING THE REPORTED PROBLEM. THE HP STATED THAT THEY DID START OVER, AND FINISHED THERAPY WITH THE NEW SUPPLIES. THE HP STATED THAT THEY DID NOT NOTICE ANYTHING DIFFERENT WITH THE SUPPLIES THAT COULD HAVE CAUSED THE ALARM. THE HP STATED THAT THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) TOLD THEM MAYBE IT WAS DUE TO THEIR PATIENT LINE CLAMP WAS CLOSED AND THAT'S WHAT CAUSED THE AIR IN THE LINE, BUT THEY ARE NOT SURE. THE HP STATED THERAPY IS GOING FINE, NOW THEY ARE DOUBLE CHECKING TO BE SURE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 77 YR