BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2855080 · Received December 3, 2012

    Report

    Report Number
    1416980-2012-06359
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 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 A SYSTEM ERROR 2240 WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE USE ERROR - OPEN CLAMP. THE LABELING REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    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 DWELL 1 OF 6. THE CARE GIVER (CG) STATED THAT THE HOME PATIENT (HP) NEEDED HELP CLEARING THE ALARMS. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THE PATIENT LINE HAD BEEN PROPERLY PRIMED PRIOR TO CONNECTION AND NO PATIENT EXTENSIONS WERE IN USE. THE PATIENT LINE HAD NOT SEPARATED FROM THE TRANSFER SET. THE PATIENT DID NOT INITIATE THERAPY PRIOR TO CONNECTING. NO DUMMY TUMMY WAS IN USE. THE PATIENT HAD NOT DISCONNECTED PRIOR TO THE ALARM. ALL OF THE BAGS WERE PROPERLY CONNECTED. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SUPPLIES. THE SET WAS NOT BEING REUSED. THE PATIENT DID NOT HAVE ANY PETS THAT COULD CAUSE DAMAGE TO THE SUPPLIES. THERE WAS NO DAMAGE NOTED ON THE OVER POUCH OR CARTON IN WHICH THE CASSETTE WAS DELIVERED, AND A SHARP OBJECT WAS NOT USED TO OPEN EITHER. THE SUPPLIES HAD NOT BEEN DAMAGED BY AN OUTLET PORT CLAMP OR ASSIST DEVICE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) FOUND THAT THE CG FORGOT TO CLOSE THE SPARE SUPPLY LINE CLAMP. THE TSR ASSISTED THE CG TO CLEAR THE ALARMS SO THAT THE CG COULD SET UP AGAIN WITH NEW SUPPLIES. THE TSR REFERRED THE CG TO HIS ON CALL REGISTERED NURSE FOR FURTHER MEDICAL INSTRUCTIONS. PROPER PROCEDURES WERE REVIEWED. THERE WERE NO SAMPLES OR LOT NUMBERS AVAILABLE. 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 70 YR HOMECHOICE