BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1904556 · Received November 22, 2010

    Report

    Report Number
    1423500-2010-06095
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 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 ISSUE WAS RESOLVED OVER THE PHONE AND THE DEVICE IS STILL IN USE; THEREFORE AN EVALUATION COULD NOT BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE CAUSE FOR THE REPORTED DIFFICULTY OF HC DEVICE SKIPPING THE INITIAL DRAIN WAS UNDETERMINED. THE DEVICE'S SERVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE DEVICE SKIPPING THE INITIAL DRAIN. 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 CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING THAT THE HOMECHOICE (HC) UNIT SKIPPED THE INITIAL DRAIN AND MOVED INTO DAY FILL 1 OF 1 DURING USE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) TO START A MANUAL DRAIN. THE HP'S DRAIN VOLUME WAS INCREASING. THE HP WAS IN MANUAL DRAIN THEN AND WOULD CONTINUE DAY EXCHANGE THERAPY WHEN DRAIN COMPLETES. DURING A FOLLOW UP WITH THE HP REGARDING THE HC MACHINE SKIPPING THE INITIAL DRAIN DURING THE DAY EXCHANGE, IT WAS REVEALED THAT THE ISSUE WAS RESOLVED AND IT DID NOT RE-OCCUR. PER HP, SHE DID NOT KNOW WHAT MIGHT HAVE CAUSED IT, AND THE HP STATED THAT SHE IS DOING FINE CONTINUING THERAPY WITHOUT FURTHER ISSUES. THE HP STATED THAT SHE HAD ONLY DRAINED ABOUT 15 ML PRIOR TO THE CALL, BUT SHE DID NOT REMEMBER HOW MUCH SHE HAD DRAINED AFTER THE TSR PLACED HER BACK ON MANUAL DRAIN. THE HP STATED THAT HER PRESCRIBED FILL VOLUME IS 2000 ML, AND SHE WAS ABLE TO CONFIRM THAT SHE HAD MANUALLY DRAINED LESS THAN HER PRESCRIBED FILL VOLUME. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    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 62 YR