BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2042139 · Received April 6, 2011

    Report

    Report Number
    1423500-2011-04146
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 18, 2011
    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 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE PRODUCT ANALYSIS LAB (PAL) EVALUATED THE DEVICE. AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS FOUND DURING EVALUATION. THE IIPV WAS CONFIRMED IN THE LOGS BUT NOT DUPLICATED DURING THE PAL EVALUATION. THE CAUSE WAS DETERMINED TO BE INSUFFICIENT DRAIN - FALSE EMPTY DETECT / USE ERROR DUE TO INAPPROPRIATE BYPASS OF THE LOW DRAIN VOLUME ALARM. 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).

    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) 2011 DURING DRAIN CYCLE 2. THE PATIENT'S DRAIN VOLUME WAS 5332ML. THE FILL VOLUME WAS 3000ML; THIS MEETS IIPV CRITERIA. PRODUCT SURVEILLANCE ATTEMPTED TO CONTACT THE NURSE ON (B)(6) 2011. THE PERITONEAL DIALYSIS SECRETARY STATED THAT THE NURSE IS CURRENTLY UNAVAILABLE. PRODUCT SURVEILLANCE LEFT A DETAILED MESSAGE WITH THE SECRETARY REGARDING THE IIPV EVENT THAT WAS FOUND DURING EVALUATION. THE SECRETARY WILL NOTIFY THE NURSE. PRODUCT SURVEILLANCE ADVISED TO HAVE THE NURSE CALL SHOULD SHE HAVE ANY QUESTIONS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR