BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2231289 · Received September 1, 2011

    Report

    Report Number
    1423500-2011-11562
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 12, 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). A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT IS CONFIRMED DUE TO THE USE ERROR DESCRIBED BY THE HOME PATIENT. THE PATIENT HAD REUSED THE DISPOSABLE SET AFTER DISCONNECTING PREVIOUSLY AFTER AN INITIAL FILL AND DAY DWELL. 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. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A LOW DRAIN VOLUME (LDV) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING INITIAL DRAIN. THE HOME PATIENT (HP) STATED THAT HE IS ON A HI DOSE THERAPY AND HE DID HIS INITIAL DRAIN AND THE DAY FILL. THE HP STATED HE THEN TURNED THE HC OFF AND THEN GOT BACK ON FOR THERAPY THAT NIGHT FOR THE NIGHT THERAPY. THAT IS WHEN HE GOT THE LOW DRAIN VOLUME ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP READ THE DISPLAY ON THE HC AND IT SAID INITIAL DRAIN. THE TSR ASKED THE HP IF HE WAS SURE HE DID THE DAY FILL AND THE HP SAID YES. THE TSR ASKED THE HP IF HE USED THE SAME SUPPLIED THAT HE USED IN THE EARLIER EXCHANGE AND HE SAID YES. THE TSR EXPLAINED THAT SUPPLIES MAY BE COMPROMISED AND ADVISED THE HP TO START OVER WITH NEW SUPPLIES. THE TSR WALKED THE HP THROUGH ENDING THERAPY PROCEDURE. THE TSR ADVISED THE HP TO CALL THE NURSE AND LET HER KNOW. THE HP WOULD START OVER WITH NEW SUPPLIES AND CALL HIS NURSE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 64 YR HOMECHOICE