BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2874428 · Received December 14, 2012

    Report

    Report Number
    1416980-2012-07427
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 27, 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). THIS COMPLAINT FOR A REPORT OF USE ERROR ? FAILED TO FOLLOW THERAPY STEPS WAS CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN TUBING) WHICH OCCURRED ON THE HOMECHOICE (HC) DURING INITIAL DRAIN. THE HOME PATIENT (HP) STATED THAT THE HC HAD A SYSTEM ERROR 2367 DISPLAY ON THE HC WHEN HE WOKE UP, AND HE NEEDED ASSISTANCE TO CONTINUE THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CYCLE THE POWER ON THE HC TO VIEW THE ALARM LOG. THERE HAD BEEN A SYSTEM ERROR 2240 PRIOR TO THE SYSTEM ERROR 2367. THE TSR EXPLAINED BOTH SYSTEM ERRORS TO THE HP. THE PATIENT LINE HAD NOT SEPARATED FROM THE TRANSFER SET AND THE PATIENT DID NOT START THERAPY PRIOR TO CONNECTING. A DUMMY TUMMY WAS NOT IN USE. ALL OF THE BAGS WERE PROPERLY CONNECTED. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SUPPLIES AND THEY HAD NOT BEEN DAMAGED BY AN OUTLET PORT CLAMP OR ASSIST DEVICE. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THE PATIENT LINE HAD BEEN PROPERLY PRIMED PRIOR TO CONNECTING. A PATIENT EXTENSION LINE WAS IN USE AND HAD BEEN CONNECTED PRIOR TO PRIME. THE PATIENT STATED THAT HE ALWAYS CONNECTS PRIOR TO PRIME AND KEEPS HIS TRANSFER SET CLOSED. THE TSR EXPLAINED THAT THE HP MUST NOT CONNECT UNTIL THE HC WAS DONE PRIMING AND SAYS "CONNECT YOURSELF". THE PATIENT ALSO STATED THAT HE ALWAYS LEAVES THE CLAMP OPEN ON THE UNUSED FINAL LINE. THE TSR ADVISED THE HP TO START OVER WITH ALL NEW SUPPLIES. THE HP UNDERSTOOD. PROPER PROCEDURES WERE REVIEWED WITH THE HP. THERE WERE NO SAMPLES OR LOT NUMBERS AVAILABLE. THE SOLUTION TO THIS ISSUE WAS PROVIDED OVER THE PHONE AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE REGISTERED NURSE ON (B)(4) 2012. SHE STATED THAT SHE DID NOT KNOW THE PATIENT WAS DOING THIS, AND THAT SHE HAD TAUGHT HIM PROPER PROCEDURES. SHE STATED THAT SHE WAS GOING TO FOLLOW UP WITH THE PATIENT AS SOON AS POSSIBLE TO REVIEW PROCEDURES AGAIN. SHE STATED THAT THE PATIENT'S THERAPY WAS GOING WELL OTHERWISE, AND NO ADVERSE EFFECTS WERE 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 56 YR HOMECHOICE