BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1992734 · Received February 15, 2011

    Report

    Report Number
    1423500-2011-02025
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 24, 2011
    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 DEVICE WAS NOT RETURNED FOR EVALUATION BY THE PRODUCT ANALYSIS LAB (PAL). THE CAUSE OF THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS DETERMINED TO BE: USE ERROR. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. 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 IS NOT AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S (B)(4) TO REQUEST ASSISTANCE ON THE HOME CHOICE (HC). PER THE INITIAL REPORT, THE CAREGIVER (CG) STATED THE HOME PATIENT (HP) STARTED CRYING IN THE INITIAL DRAIN THAT HER STOMACH WAS HURTING HER SO THE CG STOPPED THE INITIAL DRAIN, DRAIN VOLUME 24ML, LAST FILL VOLUME 600ML, THEN BYPASSED THE HP TO FILL 1 OF 9. THE HP FILLED WITH 1100ML ON TOP OF THE 576ML THAT SHE STILL HAD IN HER BELLY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED TO THE CG TO NEVER BYPASS THE INITIAL DRAIN WITHOUT CALLING THE PERITONEAL DIALYSIS NURSE (PDN) OR BAXTER FOR ASSISTANCE. THE CG THEN STOPPED THE DWELL AND BYPASSED THE HC TO DRAIN 1 OF 9 AND DRAINED 2019ML. THE CG STATED THE HP WAS OK AND DECIDED TO SWITCH TO FILL 2 OF 9 AND WOULD CONTINUE WITH THERAPY. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THIS EVENT MEETS OVERFILL CRITERIA.

    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 YR