BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1862198 · Received October 8, 2010

    Report

    Report Number
    1423500-2010-04149
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 13, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A LOW DRAIN VOLUME ALARM (LDVA) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION OF THE LDVA IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE NURSE, THE SAMPLE WOULD BE DISCARDED, AND THE LOT NUMBER WAS UNKNOWN.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 A LOW DRAIN VOLUME ALARM ON THE HOMECHOICE (HC) DISPLAY DURING INITIAL DRAIN. DURING TROUBLESHOOTING, THE HOME PATIENT (HP) REVEALED THAT THERE WERE AIR BUBBLES IN THE PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO END THE THERAPY AND ADVISED TO START OVER WITH NEW SUPPLIES. DURING A FOLLOW UP WITH THE NURSE REGARDING THE AIR IN LINE, IT WAS REVEALED THAT THE ISSUE WAS RESOLVED, AND THAT HP DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. THE NURSE STATED THAT THE HP DID NOT REPORT ANY LOOSE CONNECTIONS, DISCONNECTIONS OR DEFECTS WITH THE ISSUES WITH THE SUPPLIES. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1