BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2001092 · Received February 24, 2011

    Report

    Report Number
    1423500-2011-02433
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    December 28, 2010
    Report Date
    February 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    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 EVALUATED THE DEVICE AND FOUND AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT DURING EVALUATION. THE PROBABLE CAUSED WAS DETERMINED TO BE: INSUFFICIENT DRAIN, ONE OR MORE CYCLES ADVANCES TO NEXT FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO EXCEPTION, NONCONFORMANCE, OR REWORK HAD OCCURRED DURING THE MANUFACTURING OF THE DEVICE SERIAL NUMBER. 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) 2010 DURING DRAIN CYCLE 4. THE PATIENT'S ULTRAFILTRATION READING WAS 1386ML, INDICATING THE HOME PATIENT (HP) DRAINED 1386ML MORE THAN THEIR PROGRAMMED FILL VOLUME OF 2000ML. THIS INFORMATION MEETS IIPV CRITERIA. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(6) 2011. ACCORDING TO THE NURSE, THE PATIENT DID NOT REPORT ANY SYMPTOMS OF OVERFILL, HOWEVER, THE PATIENT WAS HOSPITALIZED FOR FLUID OVERLOAD AND WEAKNESS. THE PATIENT'S SOLUTION CONCENTRATION HAS BEEN INCREASED TO 4.25% TO PULL EXTRA FLUID. THE NURSE STATED THAT THIS HAS BEEN WORKING SUCCESSFULLY. THE PATIENT'S HOSPITALIZATION WAS RELATED TO HIS CHRONIC ANEMIA AND NOT PERITONEAL DIALYSIS THERAPY. NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR