BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1860843 · Received October 7, 2010

    Report

    Report Number
    1423500-2010-04129
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    August 5, 2010
    Report Date
    September 16, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ANALYSIS LAB (PAL) EVALUATION AND HOMECHOICE (HC) DESIGN ENGINEERS AT DEKA REVIEW OF THIS INCIDENT CONCUR THAT NO DEVICE FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THE 18 IIPVS FOUND IN THE DEVICE'S EVENT LOGS. THE DEVICE MET PERFORMANCE SPECIFICATION REQUIREMENTS RELATIVE TO THE ISSUES OF IIPV. THE PRODUCT ANALYSIS LAB (PAL) EVALUATION AND HOMECHOICE (HC) DESIGN ENGINEERS AT DEKA REVIEW OF THIS INCIDENT CONCUR THAT NO DEVICE FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THE 18 IIPVS FOUND IN THE DEVICE'S EVENT LOGS. THE DEVICE MET PERFORMANCE SPECIFICATION REQUIREMENTS RELATIVE TO THE ISSUES OF IIPV. THE DEVICE HAS NOT BEEN PREVIOUSLY RETURNED FOR ANY ISSUES RELATED TO PEDIATRIC IIPV OR TIMEOUT DURING RITE. 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). THIS IS REPORT 7 OF 18 RELATED TO IIPV INCIDENTS FOUND IN THE DEVICE'S EVENT LOGS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE BAXTER PRODUCT ANALYSIS LAB FOR EVALUATION. UPON COMPLETION OF THE EVALUATION A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING AN ERRONEOUSLY ELEVATED THYROID-STIMULATING HORMONE (TSH) RESULT ABOVE THE NORMAL REFERENCE RANGE FOR ONE PATIENT THAT WAS GENERATED BY THE UNICEL DXC 880I SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY; HOWEVER, SUBSEQUENT TESTING PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE AND AN AMENDED REPORT WAS ISSUED. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Description of Event or Problem · 1

    AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION WAS IDENTIFIED IN THE LOG OF A HOMECHOICE (HC) DEVICE. THE IIPV OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 3. THE PROGRAMMED FILL VOLUME WAS 140ML AND THE ULTRAFILTRATION READING WAS 45ML, INDICATING THE HOME PATIENT (HP) DRAINED 45ML MORE THAN THEIR PROGRAMMED FILL VOLUME OF 140ML. THIS INFORMATION GAVE A TOTAL DRAIN VOLUME OF 185ML, WHICH MEETS IIPV CRITERIA. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. THIS EVENT IS THE SEVENTH OF 18 EVENTS OF IIPV NOTED IN THE PATIENT LOGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 14 MO