BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2223582 · Received August 25, 2011

    Report

    Report Number
    1423500-2011-11268
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 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). BAXTER RECEIVED TWO COMPANION SAMPLES IN REFERENCE TO THE REPORT FOR A SYSTEM ERROR 2240 (AIR IN SET). THE SETS WERE PLACED ON A HOMECHOICE MACHINE FOR PRIMING AND THE MACHINE RAN WITH NO ALARMS. NO MANUFACTURING ABNORMALITIES WERE NOTED DURING VISUAL INSPECTION. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THIS REPORT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE REPORT WAS UNDETERMINED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPANION SAMPLE HAS BEEN REQUESTED FOR EVALUATION. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE), WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE DURING INITIAL DRAIN. THE PATIENT WAS CONNECTED. THE PATIENT STATED THE ALARM OCCURRED LAST. THE PATIENT HAD CYCLED THE POWER OFF AND ON AND A SE 2367 OCCURRED. THE PATIENT TURNED OFF THE HC, DISCONNECTED, AND PERFORMED MANUAL EXCHANGES. THE PATIENT STATED THEY CALLED THEIR NURSE WHO ADVISED THEM TO CONTACT BAXTER. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE PATIENT REVIEW THE ALARM LOG AND A SE 2240 (AIR IN SET) HAD OCCURRED PRIOR TO THE SE 2367. THE TSR EXPLAINED THE AIR DETECT ALARM, REVIEWED PROPER PROCEDURES PER THE USER MANUAL, AND ADVISED THE PATIENT TO CALL THEIR NURSE BACK AND LET THEM KNOW THE ALARM THAT OCCURRED WAS AN AIR DETECT ALARM. THE PATIENT UNDERSTOOD AND WOULD CALL THE NURSE BACK. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE PATIENT ON (B)(6) 2011 REGARDING THE REPORTED SE 2240. THE PATIENT STATED THEY DID NOT NOTICE ANY VISIBLE DAMAGE OR ABNORMALITIES WITH THE SUPPLIES IN USE AND WERE UNABLE TO DETERMINE HOW AIR MIGHT HAVE GOT INTO THE LINES. THE PATIENT STATED WHEN THEY HAD THE ALARM THEY CONTACTED THE NURSE AND WERE TOLD TO FINISH THERAPY MANUALLY. THE PATIENT SPOKE WITH THE NURSE AGAIN AFTER THAT AND THE NURSE ASSISTED THE PATIENT WITH SETTING UP THE MACHINE WITH NEW SUPPLIES. THE PATIENT WAS ABLE TO COMPLETE THERAPY SUCCESSFULLY. THE PATIENT STATED SINCE THEN THERAPY HAS BEEN GOING WELL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    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 H11E25078

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR HOMECHOICE