BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1792141 · Received August 10, 2010

    Report

    Report Number
    1423500-2010-02350
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 19, 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 DEVICE HAS BEEN RECEIVED, AND THE EVALUATION IS IN PROCESS. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE PASSED THE HOMECHOICE RETURN INSTRUMENT TEST / EVALUATION (RITE) ELECTRICAL TEST AND WAS FOUND TO MEET FUNCTIONAL SPECIFICATIONS RELATIVE TO THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) IDENTIFIED VIA THE DEVICE LOGS. THE CAUSE OF THE IIPV WAS DETERMINED TO BE: INSUFFICIENT DRAIN-ONE OR MORE CYCLE(S) ADVANCES TO NEXT FILL WHEN SLOW/ NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. 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). ADDITIONAL INFORMATION: PRODUCT SURVEILLANCE FOLLOWED UP WITH THE PERITONEAL DIALYSIS (PD) NURSE AND PROVIDED RESULTS OF DEVICE EVALUATION. NO OVERFILL SYMPTOMS WERE REPORTED BY HP PER NURSE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. HP CONTINUES PD THERAPY USING THE CYCLER.

    Description of Event or Problem · 1

    TWO INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION WERE IDENTIFIED IN THE THERAPY LOG OF A HOMECHOICE (HC) DEVICE. THIS IS REPORT 2 OF 2. THE IIPV OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 6. THE PROGRAMMED FILL VOLUME WAS 1800ML AND THE TOTAL DRAIN VOLUME WAS 2884ML. THIS DRAIN VOLUME MEETS BAXTER'S IIPV CRITERIA. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS OPERATING IN A NARROW HEAVILY CALCIFIED VESSEL IN THE PROXIMAL PART OF THE LEFT MAIN CORONARY ARTERY. TWO ATTEMPTS WERE MADE TO CROSS THE LESION WITH THE XIENCE V STENT DELIVERY SYSTEM (SDS), AFTER WHICH THE STENT WAS FOUND TO BE DISLODGED. THE SDS WAS WITHDRAWN AND AN ATTEMPT WAS MADE TO DRAW THE STENT BACK INTO THE SHEATH; HOWEVER, THIS WAS UNSUCCESSFUL. THE UNDEPLOYED STENT WAS LEFT IN THE DISTAL RADIAL ARTERY, WHERE IT REMAINS. A NON-ABBOTT STENT WAS USED TO COMPLETE THE CASE. NO PATIENT EFFECTS WERE REPORTED AND NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 73 YR