BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1930635 · Received December 16, 2010

    Report

    Report Number
    1423500-2010-06952
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 21, 2010
    Report Date
    November 21, 2010
    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 PATIENT DISCONNECTING AND NOT CAPPING OFF THE PATIENT LINE. THIS COMPLAINT CANNOT BE CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE NOT ENOUGH DATA ARE AVAILABLE WITHIN THE COMPLAINT INFORMATION TO IDENTIFY ROOT CAUSE; THEREFORE THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THE 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). THE SAMPLE WAS DISCARDED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH REVIEW CANNOT BE CONDUCTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A NEED TO END THERAPY, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE DURING DWELL 1. THE HOME PATIENT (HP) STATED THAT THEY HAD TO DISCONNECT FROM THE MACHINE BECAUSE OF AN EMERGENCY AND NOW THE HP WAS READY TO RECONNECT. THE LINE WAS NOT CAPPED. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP THAT THEY WOULD NEED TO END THERAPY AND START OVER WITH NEW SUPPLIES. THE TSR ASSISTED IN ENDING THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP) ON (B)(4) 2010 REGARDING THE REPORTED PROBLEM. 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 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR PD CYCLER