BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED

    MDR report key: 1812817 · Received August 24, 2010

    Report

    Report Number
    1423500-2010-02821
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 31, 2010
    Report Date
    July 31, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO THE PRODUCT ANALYSIS LAB FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD (DHR) REVEALED NO ISSUES WERE OBSERVED DURING MANUFACTURING OF THE DEVICE. THE CAUSE OF THE INCIDENT WAS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A SWAP OF THE DEVICE WAS REFUSED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S (B)(4) TO REPORT AN ALARM ON THE HOMECHOICE (HC) MACHINE DURING DRAIN 4 OF 4. THE PATIENT'S FILL VOLUME WAS 2500 ML. THE PATIENT HAD THREE DRAIN LINES CONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND HELPED TO CLEAR THE ALARM BACK TO DRAIN 4 OF 4. AFTER THE HOME PATIENT (HP) PRESSED STOP AND GO THE DRAIN VOLUME REACHED 4801 ML. THIS MEETS INCREASED INTRAPERITONEAL VOLUME (IIPV) CRITERIA. THE HC WAS THEN IN THE LAST FILL. THE PATIENT HAD HAD ABDOMINAL DISCOMFORT, BUT THE SYMPTOM WAS RELIEVED WITH THE DRAIN. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE SPOKE WITH THE PERITONEAL DIALYSIS (PD) REGISTERED NURSE (RN) ON (B)(6) 2010. THE PATIENT HAS BEEN DOING FINE AND HAS BEEN CONTINUING THERAPY ON THE CYCLER AS USUAL WITH NO FURTHER ISSUES. A SWAP OF THE DEVICE WAS REFUSED. THE PD RN STATED THE HP HAS BEEN TRAINED ON THE PROPER PROCEDURES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR