BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1982985 · Received February 9, 2011

    Report

    Report Number
    1423500-2011-01702
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 20, 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). THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A LOW DRAIN VOLUME ALARM WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. A ROOT CAUSE WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION. A POSSIBLE CAUSE WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR THE MACHINE STILL DISPLAYING LOW BATTERY, THE HOME PATIENT (HP) STATED THE MACHINE WAS SHOWING LOW DRAIN VOLUME ALARM. THE HP STATED HE WAS FILLED WITH AIR. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED HP HOW HE KNEW HE WAS FILLED WITH AIR, THE HP STATED THAT THE MACHINE FILLED HIM WITH AIR AND HE SEES IT COMING OUT. THE TSR ASKED HP IF THERE WAS AIR BUBBLES IN THE PATIENT LINE, THE HP STATED NO. THE TSR EXPLAINED THERE MAY BE AN ISSUE WITH THE TRANSFER SET AND RECOMMENDED THAT HE CONTACT THE NURSE. THE TSR HELPED HP END THERAPY AND MACHINE WILL BE SWAPPED. THERE WAS PATIENT INVOLVEMENT BUT NO INJURY OR MEDICAL INTERVENTION REPORTED. A FOLLOW UP WAS DONE VIA PHONE CALL. THE REGISTERED NURSE (RN) STATED THE HP TOLD HER HE HAD GAS. THE MACHINE WAS SWAPPED AND THE HP HAS HAD NO OTHER ISSUED THIS HIS MACHINE OR THERAPY.

    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 (B)(4) LO/CAL UB 2L/2