BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2200503 · Received August 11, 2011

    Report

    Report Number
    1423500-2011-10535
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    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 DEVICE WAS REQUESTED BUT WAS NOT AVAILABLE. A BATCH REVIEW WILL BE PERFORMED FOR THE LOT NUMBER PROVIDED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR THE SYSTEM ERROR 2240 (AIR IN LINE) OCCURRED DURING DRAIN WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE BATCH REVIEW WAS PERFORMED ON POTENTIALLY ASSOCIATED LOT (H11E23099) WITH NO ISSUES NOTED. THEREFORE, THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. 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

    DURING ASSISTANCE WITH TROUBLESHOOTING A SYSTEM ERROR 2240 AND 2367, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING DRAIN, THE HOME PATIENT (HP) WAS TOLD TO DISCARD SUPPLIES AND FINISH USING MANUALS OR TO START OVER. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ALSO EXPLAINED THE ALARM TO THE PATIENT. DURING A FOLLOW-UP WITH THE HOME PATIENT (HP) REGARDING THE REPORTED PROBLEM, THE HP STATED THEY DID TALK TO THEIR NURSE REGARDING THE PROBLEM. THE HP FINISHED THERAPY THAT EVENING USING MANUAL SUPPLIES. THE HP STATED THAT THERE WAS NOTHING UNUSUAL NOTICED WITH THE SUPPLIES THAT COULD HAVE CAUSED THE ALARM. THEY STATED THERAPY HAS BEEN GOING WELL SINCE THEN. 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 H11E23099

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR HOMECHOICE