BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1931552 · Received December 17, 2010

    Report

    Report Number
    1423500-2010-07000
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 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, AND THE EVALUATION IS IN PROCESS. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THIS REPORT WAS NOT CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE PREVIOUS SERVICE RECORD SHOWED THE DEVICE PASSED ALL REQUIRED TESTS AND CALIBRATIONS PRIOR TO ITS RELEASE. NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE ISSUE OF THE PATIENT INCORRECTLY CHANGING THE DRAIN SETTINGS TO BYPASS THE LOW DRAIN VOLUME ALARM. BASED ON THE INFORMATION OBTAINED FROM INVESTIGATION BY BAXTER, THE ROOT CAUSE OF THE USE ERROR WAS NOT DETERMINED. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR A USE/USER ERROR IDENTIFIED IN THIS INCIDENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORT HAS 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

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REGARDING A LOW DRAIN VOLUME (LDV) ALARM THAT APPEARED ON THE HOME CHOICE (HC) DURING INITIAL DRAIN. THE HOME PATIENT (HP) STATED THAT HE HAD SOME PROGRAM CHANGES TODAY AND THAT HE WAS STARTING TONIGHT'S THERAPY EMPTY. THE HP STATED THAT WHEN HE GOT THE LDV, INSTEAD OF BYPASSING, THE HP WENT INTO THE MAKE ADJUSTMENTS MENU AND "TOOK OUT THE INITIAL DRAIN ALARM (IDA)." GTS ADVISED THE HP TO CALL THE REGISTERED NURSE (RN) AND INFORM HER THAT HE CHANGED THE IDA AND THAT THE IDA NEEDED TO BE THERE FOR TOMORROW'S THERAPY. THE HP CONTINUED THERAPY AND WAS GOING TO CALL THE RN. FOLLOW UP WITH THE NURSE REVEALED THAT SHE WAS AWARE OF THE REPORTED PROBLEM AND THE INITIAL DRAIN ALARM (IDA) WAS RESET WITH HER. THE HP WAS RESUMING THERAPY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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