BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1911246 · Received November 30, 2010

    Report

    Report Number
    1423500-2010-06396
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(6) 2011. ACCORDING TO THE NURSE, TO HIS KNOWLEDGE, THE PATIENT HAS NOT REPORTED ANY SYMPTOMS. THE PATIENT HAS RESUMED THERAPY SUCCESSFULLY AND HAS NOT REPORTED ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE. EVALUATION SUMMARY: THE CUSTOMER REPORTED THEY FELT THE HEATER WAS NOT WORKING DURING THERAPY USING THE HOMECHOICE CYCLE. THE CYCLER WAS SWAPPED AND EVALUATED. THE REPORTED DIFFICULTY OF THE HEATER NOT WORKING/UNDER TEMPERATURE FLUID BEING DELIVERED WAS NEITHER CONFIRMED IN THE DEVICE LOGS NOR DUPLICATED DURING EVALUATION. THE PRODUCT ANALYSIS LAB EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. THE CAUSE OF THE HEATER NOT WORKING/UNDER TEMPERATURE FLUID BEING DELIVERED WAS UNDETERMINED. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED ISSUE. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REPORTED AN ISSUE WITH THE HEATER ON THE HOME CHOICE (HC) MACHINE DURING USE. THE HOME PATIENT (HP) INSISTED HAVING THE HC SWAPPED BECAUSE THE HEATER WAS NOT WORKING. THE HP WOKE UP AND HAD PAIN IN HER SHOULDERS. THE HP FELT THE HEATER BAG AND STATED THAT IT FELT COLD. THE DEVICE WAS SWAPPED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 69 YR