BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2140942 · Received June 27, 2011

    Report

    Report Number
    1423500-2011-08379
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 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 FOR A REPORT OF AIR IN THE PATIENT LINE GOING INTO THE PATIENT WAS NOT CONFIRMED. PER THE COMPLAINT INFORMATION, THE CAUSE OF THE AIR IN TUBING IS USE ERROR. 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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, AN EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. 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

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING AIR IN LINE DURING THE "CONNECT YOURSELF" STEP ON THE HOMECHOICE (HC) SYSTEM. THE HOME PATIENT (HP) HAD CONNECTED AND REALIZED THAT THERE WAS AIR IN THE PATIENT LINE AFTER PRIMING, BECAUSE THE BLUE CLAMP WAS OPEN ON THEIR UNUSED LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP WITH TROUBLESHOOTING AND ADVISED TO SETUP WITH NEW SUPPLIES SINCE THE HP HAD ALREADY CONNECTED. THE HP WAS TO SETUP WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT, BUT NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. DURING A FOLLOW-UP WITH THE HP, IT WAS FOUND THAT THE HP HAD NO IDEA HOW THE AIR ENTERED THE LINES. THE HP DID NOT NOTICE ANYTHING UNUSUAL WITH THE SUPPLIES AT USE THAT NIGHT. THE HP ADDED THAT SHE IS ONLY DOING MANUAL EXCHANGES NOW. THE HP HAD NOTIFIED HER NURSE REGARDING THE EVENT. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    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 84 YR HOMECHOICE