BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1913884 · Received December 3, 2010

    Report

    Report Number
    1423500-2010-06483
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A CHECK LINES AND BAGS ALARM. THE REPORTED CONDITION WAS NOT CONFIRMED DUE TO LACK OF PRODUCT SAMPLE. A BATCH REVIEW WAS NOT PERFORMED BECAUSE LOT INFORMATION WAS UNKNOWN. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE INCIDENT WAS NOT DETERMINED. A USE ERROR WAS IDENTIFIED DURING TROUBLESHOOTING; THE PATIENT WAS IN INITIAL DRAIN AND WANTED TO REPRIME. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. 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 SAMPLE IS NOT AVAILABLE. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK LINES AND BAGS ALARM THAT OCCURRED ON THE HOMECHOICE (HC) UNIT DURING INITIAL DRAIN. THE HP STATED THAT SHE WAS TRYING TO RE-PRIME THE PATIENT LINE; HOWEVER, WAS CONNECTED AND INITIAL DRAIN STARTED. THE HP STATED THAT THERE WAS A LOT OF AIR IN THE PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO END THERAPY AND START OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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