BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1953161 · Received January 7, 2011

    Report

    Report Number
    1423500-2011-00275
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    November 2, 2010
    Report Date
    December 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). EVALUATION SUMMARY: THE EVALUATION DID NOT CONFIRM ANY FAILURE OR MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) THAT WAS DISCOVERED DURING EVALUATION. BASED ON A REVIEW OF ALL AVAILABLE THERAPY LOG DATA, THE CAUSE OF THE IIPV WAS DETERMINED TO BE: INSUFFICIENT DRAIN / FALSE EMPTY DETECT AND USE ERROR AS THE INITIAL DRAIN ALARM SETTING WAS INAPPROPRIATELY PROGRAMMED. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE IIPV. LABELING REVIEW FOUND LABELING TO BE ADEQUATE FOR THE USER ERROR IDENTIFIED IN THIS REPORT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER; HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 1. THE PATIENT'S ULTRAFILTRATION READING WAS 1533ML, INDICATING THE HOME PATIENT (HP) DRAINED 1533ML MORE THAN THEIR PROGRAMMED FILL VOLUME OF 2000ML. THIS INFORMATION MEETS IIPV CRITERIA. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(6) 2010. ACCORDING TO THE NURSE THE PATIENT DID NOT REPORT ANY ISSUES OR SYMPTOMS OF OVERFILL TO HER. ADDITIONALLY, THE PATIENT'S FILL VOLUME HAS BEEN CHANGED TO 3000ML. THE NURSE STATED THAT THE PATIENT HAS RESUMED THERAPY JUST FINE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    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 54 YR