BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2192012 · Received August 4, 2011

    Report

    Report Number
    1423500-2011-10278
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR A LEAK WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. HOWEVER, BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE REPORT WAS USE ERROR. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING FLUID LEAKING NEAR THE HOMECHOICE, WHICH OCCURRED DURING USE DURING PRIME. THE PATIENT WAS NOT CONNECTED. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE CAREGIVER (CG) PRESS STOP TO PAUSE THE SETUP. THE CG CHECKED THE LINES AND BAGS FOUND THAT THE FLUID WAS COMING FROM THE DRAIN LINE. THE CG FORGOT TO PLACE THE LINE INTO THE DRAIN. THE TSR HAD THE CG PUT THE LINE INTO THE DRAIN OPTION AND RESUME PRIME. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE CG ON (B)(6) 2011 REGARDING THE LEAKING DRAIN LINE. THE CG CONFIRMED THAT THEY HAD STARTED THE PRIME WITHOUT PUTTING THE DRAIN LINE INTO THE DRAIN RECEPTACLE AND THAT WAS WHAT HAD CAUSED THE LEAK. THE CG STATED THEY PUT THE LINE IN THE DRAIN RECEPTACLE AND WERE ABLE TO COMPLETE THERAPY. THIS WAS AN ISOLATED EVENT. THE CG STATED THE PATIENT HAD BEEN CONTINUING THERAPY ON THE CYCLER SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR HOMECHOICE