BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1971877 · Received January 27, 2011

    Report

    Report Number
    1423500-2011-01123
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). THE NURSE CONTACTED BAXTER REGARDING THE PATIENT LINE NOT FILLING ON THE HOMECHOICE DURING PRIME. THE NURSE STATED SHE SET THE HEATER BAG LOWER THAN THE DEVICE AND THE SUPPLY BAG ON TOP. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE POSITIONING OF THE BAGS PREVENTED THE PATIENT LINE FROM FILLING. THE NURSE ALSO STATED THE PATIENT COMPLAINED TO HER ABOUT COLD SOLUTION GOING IN. THE TSR AGAIN EXPLAINED SINCE THE HEATER BAG WAS NOT ON THE DEVICE THE FLUID WAS NOT GOING TO WARM. THE ASSIGNABLE CAUSE FOR THE NURSE NOT PROPERLY POSITIONING THE HEATER AND SUPPLY BAGS WAS DETERMINED TO BE USE ERROR. LABELING WAS REVIEWED FOR RELATED USE ERROR(S) AND THERE WERE NO ISSUES AND NO LABEL DEFICIENCY. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT 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 NURSE (RN) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A PATIENT LINE NOT FILLING ON THE HOMECHOICE (HC) DURING PRIME. THE RN STATED SHE SET THE HEATER BAG LOWER THAN THE HC AND SUPPLY BAG ON TOP. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE POSITIONING OF THE BAGS PREVENTED THE PATIENT LINE FROM FILLING. THE RN ALSO STATED THE PATIENT COMPLAINED TO HER ABOUT COLD SOLUTION GOING IN. THE TSR AGAIN EXPLAINED SINCE HEATER BAG WAS NOT ON HC THE FLUID WAS NOT GOING TO WARM. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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