BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE

    MDR report key: 2122171 · Received June 13, 2011

    Report

    Report Number
    1423500-2011-07526
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 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 AIR IN TUBING (WITHOUT ALARM) WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. A ROOT 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.

    Description of Event or Problem · 1

    THE CARE GIVER (CG) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT AN ISSUE WHILE USING THE HOME CHOICE (HC) DURING USE DURING THE END OF THERAPY. THE CG REPORTED THAT THE HOME PATIENT (HP) HAD AIR IN THE PATIENT LINE WITHOUT AN ALARM. THE HP STOPPED THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE CG TO END THERAPY AND START OVER WITH NEW SUPPLIES. THE TSR ADVISED THE CG TO CONTACT THE REGISTERED NURSE (RN) REGARDING POSSIBLE AIR EXPOSURE. THE CG WAS CONTACTED ON (B)(6) 2011 REGARDING THE REPORTED PROBLEM. THE CG STATED THEY DID START OVER WITH A NEW SETUP, SO THE HP COULD FINISH OFF THERAPY. THE CG STATED THEY DID TALKED TO A RN REGARDING THE REPORTED PROBLEM, AND THEY DID GO IN FOR A CHECKUP. THE CG STATED THAT THEY BELIEVE IT WAS DUE TO A CATHETER ISSUE, THEY STATED THE CATHETER WAS BLOCKED. THE CATHETER WAS CHANGED OUT. THE HP STATED THAT EVERYTHING THERAPY WISE HAS BEEN GOING OKAY SINCE THE REPORTED PROBLEM. 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 LOW RECIRCULATION VOLUME APD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO HOMECHOICE