BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1935444 · Received December 22, 2010

    Report

    Report Number
    1423500-2010-07137
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 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). THE DEVICE IS NOT BEING RETURNED FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR THE SYSTEM ERROR 2240 (AIR IN LINE) OCCURRED DURING INITIAL DRAIN WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. NOT ENOUGH DATA IS AVAILABLE WITHIN THE COMPLAINT TO IDENTIFY ROOT CAUSE; THEREFORE, THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE HOME PATIENT (HP) DID NOT KNOW WHAT MIGHT HAVE CAUSED THE ALARM. THE HP DID NOT NOTICE ANYTHING UNUSUAL WITH THE SUPPLIES. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) AND UPON REVIEW OF THE ALARM LOG, IT WAS FOUND THERE WAS A SYSTEM ERROR 2240 (INDICATING AIR IN THE SET) THAT HAD OCCURRED PREVIOUSLY. THE PATIENT WOULD START THERAPY OVER WITH NEW SUPPLIES AND IT WAS ADVISED TO CONTACT THE PERITONEAL DIALYSIS REGISTERED NURSE. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM AND THE CAUSE OF THE ALARM WAS UNDETERMINED. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE CALLER. BAXTER PRODUCT SURVEILLANCE SPOKE WITH THE PATIENT ON (B)(6) 2010, WHO STATED THAT THE LOT NUMBER WAS UNKNOWN AND NO SAMPLES WERE AVAILABLE. SHE DID NOT KNOW WHAT MIGHT HAVE CAUSED THE ALARM AND HAD NOT NOTICED ANYTHING UNUSUAL WITH THE SUPPLIES. THE HP STATED SHE HAS NOT HAD ANY PROBLEMS SINCE. IT WAS AGAIN ADVISED TO NOTIFY THE NURSE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS 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 55 YR HOMECHOICE APD CYCLER