BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2113751 · Received June 3, 2011

    Report

    Report Number
    1423500-2011-07053
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED BY THE CUSTOMER, THEREFORE D4 IS UNKNOWN. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR, BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT'S (HP) NURSE ON (B)(4) 2011 REGARDING THE REPORTED SYSTEM ERROR. THE HP'S NURSE STATED THAT THE HP DID NOT REPORT THIS TO HER BUT THAT THE HP HAS BEEN DOING FINE. THE HP'S NURSE STATED THAT THERE HAD BEEN NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THE HP'S NURSE STATED THAT THE HP IS NO LONGER ON PERITONEAL DIALYSIS THERAPY BUT SWITCHED TO HEMO DIALYSIS ABOUT THREE MONTHS AGO. THE NURSE DID NOT GIVE THE REASON WHY. THE SE 2240 ALARM CANNOT BE CONFIRMED. THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. THE ROOT CAUSE WAS UNDETERMINED. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. 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 TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING DRAIN 4 OF 5. THE HOME PATIENT (HP) STATED THAT HE IS STILL CONNECTED TO THE HC. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) CYCLE POWER TWICE TO PRESS GO TO START AND HAD THE HP DISCONNECT AND REMOVE THE CASSETTE FROM THE HC. THE TSR EXPLAINED THE ALARM AND ASSISTED THE HP TO CLEAR THE ALARM AND ADVISED THE HP TO CONTACT HIS NURSE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR HOMECHOICE