BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2153723 · Received July 7, 2011

    Report

    Report Number
    1423500-2011-08783
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 17, 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). THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THE PROBLEM WAS NOT CONFIRMED AND THE CAUSE WAS UNDETERMINED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT AVAILABLE, THEREFORE NO EVALUATION COULD BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A PATIENT CONTACTED BAXTER HEALTHCARE TO REPORT A CHECK LINES AND BAGS ALARM ON A HOME CHOICE (HC) DURING DRAIN 4 OF 6. DURING THIS TIME, THE DRAIN VOLUME WAS 58ML A BLOCKAGE OF AIR IN THE LINE WAS NOTICED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) AS THERAPY WAS EXTENDED FOR A COUPLE OF HOURS. THE TSR HAD THE HP CLOSE ALL CLAMPS TO KEEP FLUID IN THE SETUP SO THEY COULD LOCATE THE BLOCKAGE AFTER ENDING THERAPY. THE TSR WAS ABLE TO SHOW THE HP THAT THE BLOCKAGE WAS AN AIR BUILD UP INSIDE THE CASSETTE. THE PATIENT WAS INVOLVED BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. BAXTER CONTACTED THE PATIENT ON (B)(6) 2011. THE PATIENT STATED THE FOLLOWING: NOTHING WAS KNOWN TO HAVE CAUSED THE AIR TO ENTER THE SETUP AND THE SAMPLE WAS DISCARDED. A COMPANION CASSETTE WAS REQUESTED WITH LOT NUMBER H11A22041. THERAPY HAD BEEN GOING FINE SINCE THE EVENT AND THE PATIENT STATED SHE WOULD INFORM THE NURSE THE NEXT TIME SHE WENT TO THE CLINIC. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS 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 H11A22041

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR HOME CHOICE