BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1122324 · Received August 15, 2008

    Report

    Report Number
    1423500-2008-00750
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 28, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING HOMECHOICE (HC) THERAPY AND REPORTED THAT THE HOMECHOICE DISPLAY FROZE DURING DRAIN 3/4. THE PATIENT FELT OVERFILLED AND DRAINED 5710ML. THE PATIENT'S FILL VOLUME WAS 2500ML. THE PATIENT DID NOT HAVE ANY SYMPTOMS OF BLOATING AND DISTENSION DUE TO THE OVERFILL. THE PATIENT'S NURSE STATED THAT THE MACHINE WAS NOT READING THE PROCARD CORRECTLY AND WAS GIVING AN ERROR. THE DEVICE WAS SENT BACK TO BAXTER FOR EVALUATION. THE NURSE STATED THAT THERE WAS NO INJURY OR MEDICAL INTERVENTION DUE TO THE OVERFILL. THE NURSE DID NOT HAVE ANY ADDITIONAL INFORMATION REGARDING THE INCIDENT.

    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