BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1063834 · Received June 19, 2008

    Report

    Report Number
    1423500-2008-00516
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    February 24, 2008
    Report Date
    June 10, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). ADD'L 510(K): K923065. EVALUATION SUMMARY: THE EVALUATION DID NOT CONFIRM ANY FAILURE OR MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE OVERFILL IDENTIFIED DURING THE EVALUATION. BASED ON A REVIEW OF THE DEVICE LOG DATA, IT WAS DETERMINED THAT THE PROBABLE CAUSE OF THIS OVERFILL WAS USER ERROR/INAPPROPRIATE BYPASS OF INITIAL DRAIN. THE DEVICE WAS ROUTED TO THE SERVICE AREA.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, A BAXTER TECHNICIAN IDENTIFIED A POTENTIAL OVERFILL SITUATION. DURING DRAIN 1 OF THERAPY ON (B) (6) 2008, THE HOME PATIENT HAD AN ULTRAFILTRATION (UF) OF 1311ML. THIS INDICATES THAT THE PATIENT DRAINED 3311ML FOLLOWING A FILL VOLUME OF 2000ML (2000ML+1311ML=3311ML). A FOLLOW UP CALL WAS MADE TO THE HOME PATIENT'S NURSE STATED THAT SHE REMEMBERED THE PATIENT HAVING SOME DRAINING DIFFICULTIES IN (B) (6), BUT THAT THE PATIENT HAD NO SYMPTOMS OF OVERFILL. THE NURSE HAD NO FURTHER INFORMATION REGARDING THIS EVENT. THE PATIENT HAS SUCCESSFULLY BEEN COMPLETING THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    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