BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1896136 · Received November 10, 2010

    Report

    Report Number
    1423500-2010-05571
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 23, 2010
    Report Date
    October 24, 2010
    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 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 FOR THE LDVA IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. 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

    DURING TROUBLESHOOTING A LOW DRAIN VOLUME (LDV) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING INITIAL DRAIN, THE HOME PATIENT (HP) REPORTED THAT HE SAW A LOT OF AIR BUBBLES IN THE PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) STARTED TO TROUBLESHOOT THE AIR BUBBLE ISSUE, AND THE HP WAS NOT SURE HOW THE AIR GOT INTO THE LINE. THE TSR SUGGESTED TO END THERAPY AND START OVER WITH NEW SUPPLIES. DURING A FOLLOW UP WITH THE HP'S WIFE REGARDING THE AIR BUBBLES ISSUE, IT WAS REVEALED THAT THE ISSUE WAS RESOLVED BY STARTING OVER WITH NEW SUPPLIES; HOWEVER, SHE WAS NOT SURE WHAT HAD CAUSED THE AIR TO GET IN THE LINE. THE WIFE VERIFIED THAT SHE HAD NOT NOTICED ANY LOOSE CONNECTION, DISCONNECTIONS OR DEFECTS ON THE SUPPLIES. PER WIFE, HP DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. 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 77 YR