BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2042506 · Received April 6, 2011

    Report

    Report Number
    1423500-2011-04150
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 20, 2011
    Report Date
    March 20, 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 USER ERROR. THE PATIENT CHANGED OUT THE CASSETTE HOWEVER REUSED THE SOLUTION BAGS. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WAS NOT CONDUCTED. COMPLAINT WAS NOT CONFIRMED. PER THE COMPLAINT INFORMATION, THE CAUSE OF THE COMPLAINT IS USER ERROR/ MIS-USE. 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.

    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

    DURING TROUBLESHOOTING FOR A CHECK LINES AND BAGS ALARM, THE HOME PATIENT (HP) STATED THAT HE CHECKED THE LINES AND COULDN'T FIND ANYTHING WRONG SO HE TURNED OFF THE MACHINE AND CHANGED THE CASSETTE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT HE WILL NEED TO END THERAPY AND THAT HE SHOULD NOT CHANGE ANY PART OF THE SETUP ONCE THE SETUP IS COMPLETE. 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 CALL. THE HP STATED THAT AFTER STARTING OVER WITH NEW SUPPLIES NO FURTHER ISSUES WERE FOUND. THE HOME PATIENT ALSO STATED THAT THEY HAVE ALREADY DISPOSED OF THE SUPPLIES AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    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 69 YR HOMECHOICE