BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3082519 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10648
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A SYSTEM ERROR 2240 DURING THE INITIAL DRAIN STAGE. THE DISPOSABLE SET WAS NOT RETURNED TO BAXTER AND THERE WAS NO REPORT OF ISSUES THAT MIGHT HAVE CAUSED THE ALARM. THE LOT NUMBER WAS NOT PROVIDED, SO NO BATCH REVIEW COULD BE PERFORMED. ALTHOUGH THE HOME PATIENT WAS NOT SURE IF THE PATIENT LINE PRIMED COMPLETELY, INSUFFICIENT INFORMATION WAS PROVIDED TO DETERMINE THE CAUSE OF THE ALARM. THEREFORE, THE COMPLAINT CANNOT BE CONFIRMED AND THE ASSIGNABLE CAUSE WAS NOT DETERMINED. PER THE PATIENT AT-HOME GUIDE, USERS ARE INSTRUCTED CHECK THE LINES AFTER PRIME TO MAKE SURE THERE IS NO AIR IN THE LINE, PRIOR TO CONNECTING FOR THERAPY. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. 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 (SE) 2240 (AIR IN SET); WHICH OCCURRED ON THE HOMECHOICE (HC) DURING INITIAL DRAIN. THE HOME PATIENT (HP) WAS NOT SURE IF THE PATIENT LINE PRIMED COMPLETELY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CYCLE THE POWER TO END THERAPY. THE TSR ADVISED THE HP TO START OVER WITH NEW SUPPLIES. THE HC WAS OPERATIONAL. THE SAMPLES ARE UNAVAILABLE FOR EVALUATION. 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
    185323 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR HOMECHOICE