BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1760717 · Received July 19, 2010

    Report

    Report Number
    1423500-2010-01529
    Event Type
    Malfunction
    Date Received
    July 19, 2010
    Date of Event
    June 9, 2010
    Report Date
    June 29, 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 OF THE DEVICE HAS BEGUN, HOWEVER, HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE EVALUATION A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE PRODUCT ANALYSIS LAB EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) FOUND IN THE DEVICE LOGS. THE ASSIGNABLE CAUSE OF THE IIPV FOUND IN THE LOGS WAS DETERMINED TO BE: FALSE EMPTY DETECT AND USE ERROR AS THE CLINICIAN INAPPROPRIATELY SET THE MINIMUM DRAIN VOLUME PERCENT TOO LOW (75%). LABELING REVIEW FOUND LABELING TO BE ADEQUATE FOR THE USE ERROR IDENTIFIED IN THIS REPORT. 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

    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 DRAIN VOLUME WAS 3951ML. THE LARGEST PRESCRIBED FILL VOLUME WAS 2400ML, WHICH MEETS IIPV CRITERIA. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(6) 2010. ACCORDING TO THE NURSE THE PATIENT DID NOT REPORT THIS EVENT. ADDITIONALLY, THE PATIENT DID NOT REPORT ANY SYMPTOMS OF OVERFILL. THE PATIENT IS TEMPORARILY ON HOLD AS SHE IS ON HEMODIALYSIS. THE NURSE DID NOT PROVIDE ANY FURTHER INFORMATION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    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 3. THE PATIENT'S ULTRAFILTRATION READING WAS 1769ML, INDICATING THE HOME PATIENT (HP) DRAINED 1769ML MORE THAN THEIR PROGRAMMED FILL VOLUME OF 2800ML. THIS INFORMATION MEETS IIPV CRITERIA. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(6) 2010. ACCORDING TO THE NURSE THE PATIENT DID NOT REPORT ANY EXCESSIVE DRAIN VOLUMES OR OVERFILL SYMPTOMS. THE PATIENT HAS RESUMED THERAPY AND IS DOING 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 HOMECHOICE CYCLER-REFURBISHED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR