BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1871940 · Received October 16, 2010

    Report

    Report Number
    1423500-2010-04522
    Event Type
    Malfunction
    Date Received
    October 16, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT SURVEILLANCE SPOKE WITH PERITONEAL DIALYSIS NURSE (PDN) ON (B)(6) 2010, WHO VERIFIED THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS INCIDENT. THE PDN CONFIRMED THE HP IS EDUCATED ON THE PROPER THERAPY PROCEDURES. THIS COMPLAINT FOR THE SYSTEM ERROR 2240 (AIR IN LINE) THAT OCCURRED DURING DWELL 1 OF 5 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH REVIEW CANNOT BE CONDUCTED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED (B)(6) TO REPORT A SYSTEM ERROR (SE) 2240 ALARM (INDICATING AIR IN THE SET) ON THE HOMECHOICE (HC) MACHINE DURING DWELL 1 OF 5. THE HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE ALARM AND THE CAUSE OF THE ALARM WAS UNDETERMINED. THE HP WOULD RESTART THERAPY WITH NEW SUPPLIES. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE CALLER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    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 62 YR