BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1070521 · Received July 1, 2008

    Report

    Report Number
    1423500-2008-00581
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    March 29, 2008
    Report Date
    June 9, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVALUATION SUMMARY: THE EVALUATION DID NOT CONFIRM ANY FAILURE OR MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS OVERFILL DISCOVERED DURING EVALUATION. BASED ON A REVIEW OF ALL OF THE AVAILABLE THERAPY LOG DATA, THE EVALUATION HAS DETERMINED THE PROBABLE CAUSE OF THIS OVERFILL TO BE: INSUFFICIENT DRAIN, AND MULTIPLE CYCLES ADVANCED TO FILL WHEN SLOW/NO FLOW CONDITION OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. THE DEVICE WILL BE ROUTED TO THE SERVICE AREA.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, A POSSIBLE OVERFILL SITUATION WAS IDENTIFIED WHICH OCCURRED ON (B) (6) 2008, DURING THE INITIAL DRAIN. THE PATIENT'S ULTRAFILTRATION READING WAS 507ML INDICATING THE HOME PATIENT (HP) DRAINED 507ML MORE THAN THEIR PROGRAMMED LAST FILL VOLUME OF 200ML. THIS INFORMATION GIVES A TOTAL DRAIN VOLUME OF 707ML (200ML + 507ML). DURING A FOLLOW-UP CALL WITH THE HOME PATIENT'S (HP) NURSE, THE NURSE STATED THAT THE HP DID NOT REPORT EXPERIENCING ANY SYMPTOMS OF FULLNESS OR DISCOMFORT ASSOCIATED WITH THIS EVENT. THE HP'S NURSE ALSO REPORTED THAT THE HP HAD CARDIAC ISSUES, ABDOMINAL ISCHEMIA, AND ABDOMINAL SURGERY FOR A BOWEL OBSTRUCTION, AN UMBILICAL HERNIA, AND A PERFORATED BOWEL, WHICH NECESSITATED PULLING HER CATHETER. THE NURSE DID NOT HAVE INFORMATION ON SPECIFIC DATES OF THESE OCCURRENCES BUT DID STATE THAT ALL THESE ISSUES BEGAN AT THE END OF APRIL AND CONTINUED THROUGH THE END OF MAY. THE NURSE ALSO STATED THAT THE HP HAS AMBULATION ISSUES AND WAS IN A REHABILITATION CENTER FOR THE ENTIRE MONTH OF MAY FOR THIS REASON. THE NURSE WAS ADAMANT THAT NONE OF THESE OCCURRENCES HAD ANYTHING TO DO WITH THE PERITONEAL DIALYSIS; THEY WERE JUST AN ANATOMICAL OCCURRENCE. THE NURSE INDICATED THAT THERE WAS NO ALLUSION TO ANY PATHOLOGICAL OR EQUIPMENT INTERFERENCE WITH THESE ISSUES. THE PATIENT IS CURRENTLY ON IN-CENTER HEMODIALYSIS AND WILL START HOME HEMODIALYSIS TRAINING IN JULY. THE NURSE ALSO INDICATED THAT THE HP'S SISTER WILL BE MOVING IN WITH THE HP IN ORDER TO PERFORM THE HOME HEMODIALYSIS. THE NURSE THEN STATED THE HP IS CURRENTLY PROGRESSING TO IMPROVEMENT AND IS DOING VERY WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED 78FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR