BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1810502 · Received August 20, 2010

    Report

    Report Number
    1423500-2010-02774
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 4, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. HOWEVER, THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION AS OF YET. IF THE SAMPLE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS FOR A SYSTEM ERROR 2240 (AIR IN SET) THAT OCCURRED DURING DWELL 3 OF 4. THE ACTUAL SAMPLE WAS AVAILABLE AND THE REPORTED ISSUE WAS NOT CONFIRMED IN THE LAB. SET WAS VISUALLY INSPECTED WITH SOLUTION NOTED IN SET. SET WAS PLACED ON MACHINE FOR PRIMING AND RUN WITH NO ALARMS NOTED. NO MANUFACTURING ABNORMALITIES WERE NOTED DURING VISUAL INSPECTION. THE COMPLAINT COULD NOT BE CONFIRMED IN THE LAB. THE BATCH REVIEW WAS PERFORMED ON POTENTIALLY ASSOCIATED LOTS (H10E15013) WITH NO ISSUES NOTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S GLOBAL TECHNICAL SERVICE CENTER TO REPORT A SYSTEM ERROR 2240 (INDICATING AIR IN THE SET) ON THE HOMECHOICE MACHINE DURING DWELL 3 OF 4. THE HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE ALARM AND THE CAUSE OF THE ALARM WAS UNDETERMINED. THE HP ENDED THERAPY, BUT SAVED THE SETUP. THE CASSETTE WAS REQUESTED FOR EVALUATION. THE HP NOTIFIED THE PERITONEAL DIALYSIS REGISTERED NURSE IN THE MORNING AND DID A MANUAL EXCHANGE THE NEXT MORNING AND AFTERNOON, GETTING BACK ON THE REGULAR THERAPY SCHEDULE. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE CALLER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY, A PT FELL OUT OF THE BED IN THE ICU DEPARTMENT. IT WAS REPORTED, THE BED EXIT ALARM WAS SET, HOWEVER, IT IS ALLEGED THE ALARM DID NOT GO OFF WHEN THE PT EXITED THE BED AND THE PT FELL. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H10E15013

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR