BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2935203 · Received January 30, 2013

    Report

    Report Number
    1416980-2013-02264
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 26, 2013
    Report Date
    January 26, 2013
    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 COMPLAINT WAS CONFIRMED. THE CAUSE OF THE USE ERROR WAS UNDETERMINED. THIS REPORT OF USE ERROR WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION THEREFORE NO FURTHER INVESTIGATION WILL BE PERFORMED.

    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 3. THE HOME PATIENT (HP) STATED THAT HE CLEARED THE ALARM, WHICH WAS THEN FOLLOWED BY A SYSTEM ERROR 2367. THE HP HAD NOT DISCONNECTED HIMSELF AND PROCEEDED TO SETUP. THE HC WAS THEN IN PRIME. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP PRESS STOP AND DISCONNECT USING ASEPTIC TECHNIQUE. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THE PATIENT LINE HAD BEEN PROPERLY PRIMED PRIOR TO CONNECTING AND NO PATIENT EXTENSIONS WERE IN USE. THE PATIENT HAD NOT DISCONNECTED PRIOR TO THE ALARM. THE SUPPLIES HAD NOT BEEN DAMAGED BY AN OUTLET PORT CLAMP OR ASSIST DEVICE. THE HP STATED THAT HIS SUPPLY BAG HAD FALLEN OFF OF THE SHELF, LOOSENING THE CONNECTION. THE TSR ADVISED THE HP TO CALL FOR TROUBLESHOOTING ASSISTANCE PRIOR TO CLEARING A SYSTEM ERROR. THE HP THEN STATED THAT HE FELT BLOATED. THE HP STATED THAT HE WAS NOT SURE IF IT WAS DUE TO THE THREE GLASSES OF WATER HE HAD DRANK THE PREVIOUS NIGHT. THE TSR HAD THE HP CONNECT TO AN ULTRABAG IN ORDER TO DRAIN. THE HP DRAINED 2400ML. THE HP'S FILL VOLUME WAS EQUAL TO 2000ML, AND THE LAST FILL VOLUME WAS EQUAL TO 300ML. THE HP'S DRY WEIGHT WAS SET TO 150. THE DRAIN VOLUME WAS NORMAL. THE HP HAD QUESTIONS ABOUT THE AMOUNT OF WATER THAT HE COULD DRINK DURING THERAPY. THE TSR ADVISED THE HP TO FOLLOW UP WITH HIS PERITONEAL DIALYSIS REGISTERED NURSE, AND TO ALSO LET HIS NURSE KNOW ABOUT MISSED THERAPY. 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
    41341 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR HOMECHOICE