BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1822117 · Received September 1, 2010

    Report

    Report Number
    1423500-2010-03050
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    July 30, 2010
    Report Date
    August 10, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION HAS BEGUN, HOWEVER, HAS NOT YET BEEN COMPLETED. A FOLLOW UP MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE PRODUCT ANALYSIS LAB EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE INCREASED INTRAPERITONEAL VOLUME (IIPV) THAT WAS FOUND IN THE DEVICE LOGS. THE CAUSE OF THE IIPV WAS DETERMINED TO INSUFFICIENT DRAIN-FALSE EMPTY DETECT AND USE ERROR DUE TO INAPPROPRIATE BYPASS OF THE LOW DRAIN VOLUME ALARM / CLINICIAN INAPPROPRIATELY SET THE MINIMUM DRAIN VOLUME PERCENT SETTING TOO LOW. LABELING REVIEW FOUND LABELING TO BE SUFFICIENT FOR THE USE ERROR IDENTIFIED IN THIS COMPLAINT. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 4. THE PATIENT'S DRAIN VOLUME WAS 3663ML. THE FILL VOLUME WAS 2100ML. THIS MEETS IIPV CRITERIA. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON 8/31/2010 REGARDING THE IIPV FOUND DURING EVALUATION. ACCORDING TO THE NURSE, THE PATIENT DID NOT REPORT ANY SYMPTOMS OF OVERFILL TO HER. ADDITIONALLY, THE NURSE HAS THE PATIENT'S LOGS AND DRAIN VOLUMES AND DOES NOT SEE ANY DRAIN VOLUMES AS HIGH AS THIS EVENT. THE NURSE STATED THAT THE PATIENT RESUMED THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    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 79 YR