BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2771064 · Received October 3, 2012

    Report

    Report Number
    1416980-2012-01499
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 18, 2012
    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 PROBLEM WAS NOT CONFIRMED AND THE ROOT CAUSE WAS UNDETERMINED. PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. 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

    A CARE GIVER (CG) CONTACTED GLOBAL TECHNICAL SERVICE (GTS) ON (B)(6) 2012 REGARDING AN INCOMPLETE PRIME THAT OCCURRED ON THE HOME CHOICE (HC). THE CG STATES THAT THE HC DID NOT PRIME THE PATIENT LINE PROPERLY AND THEN PROCEEDED INTO INITIAL DRAIN. THE CG STATED THAT THE HP WAS NOT CONNECTED TO THE HC AND SHE DISCONNECTED THE SOLUTION BAGS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE CG TO END THERAPY AND START OVER WITH ALL NEW SUPPLIES. THE HC WAS OPERATIONAL AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED. PRODUCT SURVEILLANCE (PS) CONTACTED THE CARE GIVER (CG) ON (B)(6) 2012 . PER THE CG, THEY STARTED OVER WITH NEW SUPPLIES AND COMPLETED THERAPY SUCCESSFULLY. THE CG MENTIONED THAT THERE WAS A SMALL LEAK IN THE TUBING AND EXCESS AIR IN THE PATIENT LINE. THE FLUID DID NOT COME IN CONTACT WITH THE CAREGIVER OR PATIENT. THERAPY HAS BEEN GOING WELL SINCE THE EVENT. NO FURTHER INFORMATION CAN BE OBTAINED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT ON (B)(6) 2012 AND SHE SAID SHE COULD NOT RECALL WHICH CASSETTE LINE THAT THE LEAK WAS ON. SHE WAS UNABLE TO LOCATE THE SOURCE OF THE LEAK ON THE CASSETTE LINE. SHE DID SAY SHE SAW AIR BUBBLES THOUGH IN THE PATIENT LINE. THERE WAS PATIENT INVOLVEMENT BUT 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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR HOME CHOICE