BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1991330 · Received February 15, 2011

    Report

    Report Number
    1423500-2011-01974
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 29, 2011
    Report Date
    January 29, 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 COMPLAINT IS FOR A REPORT OF A CHECK SUPPLY LINE ALARM. THE PATIENT STATED THE SPIKED WAS NOT COMPLETELY SEATED IN THE SUPPLY BAG. THE USED SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION THEREFORE THE COMPLAINT CANNOT BE CONFIRMED IN THE LAB. FROM THE DATA WITHIN THE COMPLAINT INFORMATION, THE ROOT CAUSE WAS USER ERROR. A LABEL REVIEW WAS PERFORMED AND THE REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. 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 RENQ-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING INVESTIGATION BY BAXTER, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK SUPPLY LINE ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING THE PRIME. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE CUSTOMER PUSH THE SPIKE INTO THE SUPPLY BAG SINCE IT WAS NOT ALL THE WAY IN. THE TSR INSTRUCTED TO PRESS STOP AND GO AND THE HC WAS PRIMING FINE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. A FOLLOW UP WAS DONE VIA PHONE; THE HP HAS CONTINUED THERAPY NO INJURY OR MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR HOME CHOICE CYCLER