BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2103040 · Received May 25, 2011

    Report

    Report Number
    1423500-2011-06498
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    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). THE AIR IN TUBING (WITHOUT ALARM) IS CONFIRMED DUE TO USE ERROR - PATIENT CONNECTED BEFORE PRIMING DESCRIBED BY THE HOME PATIENT. THE PATIENT PRESSED GO TO ENTER INITIAL DRAIN PRIOR TO CONNECTING AND ALSO DID NOT REPRIME BEFORE CONNECTING, ALLOWING AIR INTO THE DISPOSABLE SET. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER NEEDING ASSISTANCE TO END THERAPY. THE HOME PATIENT (HP) STATED THAT HE PRESSED GO ON THE HOMECHOICE (HC) UNIT WITHOUT CONNECTING HIMSELF AND THE HC WENT TO INITIAL DRAIN. THE HP THEN CONNECTED HIMSELF AND DID INITIAL DRAIN. WHEN THE HC WENT TO FILL, THE HP PRESSED STOP AND WANTS TO NOW START OVER WITH NEW SUPPLIES DUE TO HAVING AIR IN THE PATIENT LINE. THE FILL VOLUME WAS 0ML. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO END THERAPY. THE HP WOULD START OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. DURING FOLLOW UP THE NURSE STATED THE EVENT HAD NOT BEEN REPORTED TO HER AND THE PATIENT IS CURRENTLY PERFORMING THERAPY FINE AS THEY JUST SAW THE PATIENT TODAY.

    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 - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR HOMECHOICE