BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1962001 · Received January 17, 2011

    Report

    Report Number
    1423500-2011-00692
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    December 31, 2010
    Report Date
    January 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) MANUAL OFF CYCLER DRAIN VOLUME OF 490 ML ON (B)(6). THE CAUSE OF THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS UNDETERMINED. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. 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). THE DEVICE HAS NOT YET BEEN RECEIVED BUT AN EVALUATION IS EXPECTED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REQUEST ASSISTANCE ON THE HOME CHOICE (HC). PER THE INITIAL REPORT, THE PERITONEAL DIALYSIS NURSE (PDN) WAS CALLING TO ARRANGE FOR SWAP AFTER THE PDN REPORTED AN OVERFILL. THE PDN DID NOT HAVE THE OCCURRENCE DATE BECAUSE THE HOME PATIENT (HP) HAS BEEN IN THE HOSPITAL FOR UNRELATED ILLNESS BUT STATED THE HP'S MOTHER STATED CALLED BAXTER WHEN IT HAPPENED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) OBTAINED INFORMATION FOR SWAP. THE PDN STATED THE HP STILL HAS SOME KIDNEY FUNCTION SO SHE WOULD ALLOW HIM TO SKIP THERAPY THIS NIGHT. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. ON (B)(6) 2011, PRODUCT SURVEILLANCE CONTACTED THE HP'S CAREGIVER (CG) REGARDING THE REPORT OF OVERFILL. THE CG STATED THE EVENT OCCURRED ON (B)(6) 2010. THE CG STATED THE LARGEST PRESCRIBED FILL VOLUME (LPFV) IS 270ML. THE CG STATED THE HP WAS TAKEN TO THE EMERGENCY ROOM FOR PAIN AND DISCOMFORT WHERE A MANUAL DRAIN WAS PERFORMED, DRAIN VOLUME 490ML. THE CG STATED AFTER SEVERAL HOURS OF CONSOLING THE HP AND DRAINING, THE SYMPTOMS WERE RELIEVED.

    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 9 MO