BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2070064 · Received April 26, 2011

    Report

    Report Number
    1423500-2011-05068
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 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). THIS COMPLAINT FOR A SYSTEM ERROR (SE) 2240 (AIR IN SET) OCCURRED DURING DWELL 4 /4 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE THE BATCH REVIEW WAS PERFORMED ON POTENTIALLY ASSOCIATED LOT (H11B22064) WITH NO ISSUES NOTED. LABEL REVIEW WAS NOT PERFORMED NO USER ERROR WAS SUSPECTED. 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 (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS KNOWN, BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT SYSTEM ERROR (SE) 2240 WHICH OCCURRED ON HOME CHOICE (HC) DURING USE DURING DWELL 4 OF 4. THE HP STATED THAT THERE WERE 3 BAGS CONNECTED. THE SOLUTION WAS IN THE FINAL BAG ONLY, AND NO BAGS HAD BEEN DISCONNECTED. THERE WERE NO LEAKS. THE HP WILL COMPLETE THERAPY WITH MANUAL SUPPLIES. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THE WRITER CONTACTED THE HOME PATIENT (HP) ON (B)(6) 2011 REGARDING THE REPORTED PROBLEM. THE HP STATED THAT THEY DID FINISH THERAPY USING MANUAL SUPPLIES. THE HP STATED THAT THE PROBLEM OCCURRED BECAUSE ONE OF THE CLAMPS BROKE ON THE SET DURING THERAPY. THE HP STATED THAT THEY ARE NOT SURE WHY IT DID THAT BUT THEY BELIEVE IT WAS WHAT CAUSED THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H11B22064

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR