BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2072641 · Received April 29, 2011

    Report

    Report Number
    1423500-2011-05179
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 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 CONNECTION ISSUE WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. DURING INVESTIGATION BY BAXTER THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE, A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED. ROOT CAUSE WAS DETERMINED TO BE USE ERROR- INCOMPLETE CONNECTION. LABELING REVIEW FOUND LABELING TO BE ADEQUATE FOR THE USE ERROR IDENTIFIED IN THIS COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING INVESTIGATION BY BAXTER, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE, A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REPORTED THAT THE CATHETER WAS NOT ALL THE WAY CONNECTED TO THE PATIENT LINE. THE PATIENT NOTICED THIS CONNECTION ISSUE DURING FILL 1. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HOME PATIENT (HP) TO CYCLE POWER OFF/ON AND START OVER WITH ALL NEW SUPPLIES AND MAKE SURE TO DRAIN FIRST. PRODUCT SURVEILLANCE CONTACTED THE PATIENT ON 04/28/2011. ACCORDING TO THE PATIENT, THERE WAS NO DEFECT WITH THE SUPPLIES. THE PATIENT STATED THAT IT WAS USE ERROR AS THE PATIENT DID NOT FULLY INSERT THE LINE. THE PATIENT STATED THAT EVERYTHING HAS BEEN FINE SINCE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    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 52 YR HOMECHOICE