BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1840019 · Received September 21, 2010

    Report

    Report Number
    1423500-2010-03570
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED ISSUE OF THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS NOT CONFIRMED IN THE LOGS OR DUPLICATED. THE CAUSE FOR THE REPORTED IIPV WAS DETERMINED TO BE INSUFFICIENT DRAIN AND FALSE EMPTY DETECT DUE TO USE ERROR: INAPPROPRIATE BYPASS OF THE CAUTION: NEGATIVE UF ALARM. LABELING REVIEW FOUND THE LABELING TO BE ADEQUATE 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 A CALL TO BAXTER'S TECHNICAL SERVICE CENTER, A NURSE REPORTED THAT THE HOME PATIENT (HP) TURNED THE HOMECHOICE (HC) OFF BECAUSE SHE FELT OVERFILLED DURING DWELL 4 OF 7. THE NURSE STATED THAT THE HP DOES NOT CURRENTLY HAVE SYMPTOMS. THE NURSE STATED THAT THE PATIENT GETS NEGATIVE ULTRAFILTRATION (UF) ALARMS AND BYPASSES A COUPLE OF TIMES TO RESOLVE THE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) RECOMMENDED THAT THE HP CONTACT BAXTER BEFORE SHE BYPASSES. THE NURSE STATED THAT THE HP MANUALLY DRAINED OUT 3000ML. THE HP'S THERAPY WAS SET TO TIDAL. THE FILL VOLUME WAS 1700ML. THIS MEETS INCREASED INTRA-PERITONEAL VOLUME (IIPV) CRITERIA. THE TSR EXPLAINED THAT THE HC WILL BE SWAPPED. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(6) 2010 REGARDING THE REPORTED OVERFILL. ACCORDING TO THE NURSE THE PATIENT IS FINE AND RESUMED THERAPY. THE PATIENT IS NOW ON CONTINUOUS AMBULATORY PERITONEAL DIALYSIS. THE NURSE DID NOT HAVE ANY DETAILS AS TO WHY THE PATIENT DRAINED 3L. 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 59 YR