BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1884322 · Received October 27, 2010

    Report

    Report Number
    1423500-2010-04981
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    July 10, 2010
    Report Date
    July 10, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SUPPLIES WERE DISCARDED AND THE LOT NUMBER IS UNKNOWN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE AND BATCH REVIEW WAS NOT PERFORMED SINCE LOT NUMBER INFORMATION WAS NOT AVAILABLE. THE ROOT CAUSE COULD NOT BE IDENTIFIED. RENAL QUALITY ENGINEERING, ALONG WITH PLANT QUALITY AND MANUFACTURING PERSONNEL, WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT THE HOMECHOICE (HC) WAS PULLING TOO MUCH FLUID DURING THE PRIME CYCLE. THE CAREGIVER STARTED OVER WITH NEW SUPPLIES. FOLLOW UP WITH THE NURSE, REGARDING THE ALARM AND THE HC PULLING TOO MUCH FLUID DURING PRIME, REVEALED THAT THE PATIENT NEVER INFORMED HER THAT HE WAS HAVING THESE ISSUES. THE NURSE STATED THAT THE PATIENT IS DOING WELL ON THE NEW CYCLER WITH NO REPORTED ISSUES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR