BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1802196 · Received August 17, 2010

    Report

    Report Number
    1423500-2010-02572
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    June 16, 2010
    Report Date
    July 13, 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). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE OF THE REPORTED PROBLEM OF OVERDELIVERY / INCREASED INTRAPERITONEAL VOLUME IS CURRENTLY BEING INVESTIGATED THROUGH CAPA NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION EXPECTED BUT NOT YET COMPLETED. ANY RESULTS OF EVALUATION WILL BE PROVIDED IN A FOLLOW UP E MDR.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: THE DEVICE EVALUATION WAS INADVERTENTLY NOT INCLUDED IN THE INITIAL REPORT. DEVICE EVALUATION: THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RETURN INSTRUMENT TEST / EVALUATION (RITE) TESTING. THE DEVICE PASSED BOTH THE HOME CHOICE RITE ELECTRICAL TEST AND THE RITE FUNCTIONAL TEST. THE ASSIGNABLE CAUSE FOR THE IIPV WAS UNDETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA STUDY THAT APPROXIMATELY 2 MONTHS POST RX VISION STENT IMPLANTATION IN THE DISTAL AND MID RIGHT CORONARY ARTERY (DRCA, MRCA), THE STENTS WERE FOUND TO BE RESTENOSED. THE DRCA HAD 80% IN-STENT RESTENOSIS (ISR) AND THE MRCA HAD 70% ISR. AN RX XIENCE STENT WAS PLACED WITHIN EACH STENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND ONE DAY POST PROCEDURE THE PATIENT WAS DISCHARGED TO HOME. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    DURING INITIAL ASSESSMENT, AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION WAS IDENTIFIED WHICH OCCURRED ON DATE (B)(6) 2010 DURING DRAIN CYCLE 5. THE ULTRAFILTRATION (UF) WAS 1755 ML. THE PROGRAMMED FILL VOLUME WAS 2500ML. THIS EVENT MEETS OVERFILL CRITERIA. ON (B)(6) 2010, PRODUCT SURVEILLANCE FOLLOWED UP WITH THE NURSE AND PROVIDED THE RESULTS OF EVALUATION AND THE PROBABLE CAUSE IDENTIFIED. THE NURSE REPORTED THAT THE PATIENT WAS DOING WELL ON THE NEW CYCLER WITH NO REPORTED ISSUES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    THE PHYSICIAN SUCCESSFULLY IMPLANTED SEVEN COILS INTO THE ANEURYSM AND PLACED A STENT. AS THE EIGHTH COIL (SUBJECT DEVICE) WAS INSERTED INTO THE ANEURYSM, A PORTION OF THE COIL PROTRUDED THROUGH THE STENT STRUT. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE PROTRUDING COIL AND IT BECAME KNOTTED AND GOT STUCK. THE PHYSICIAN PERSISTED IN AN ATTEMPT REMOVE THE COIL AND IT BROKE. THE COIL WAS TACKED TO THE VESSEL WALL WITH ANOTHER STENT. THE PROCEDURE WAS COMPLETED AND THE PATIENT IS REPORTED TO BE IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY/FKX FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR