BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE

    MDR report key: 2042638 · Received April 6, 2011

    Report

    Report Number
    1423500-2011-04162
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR HOLES IN THE CASSETTE OVERPOUCH COULD NOT BE CONFIRMED IN THE LAB. A PICTURE OF THE UNUSED UNIT WAS RETURNED TO BAXTER FOR COMPLAINT INVESTIGATION. THE PICTURE WAS VISUALLY INSPECTED AND IT WAS NOTED THAT THE ONLY HOLES IN THE POUCH WAS THE FLUTTER VENTS. NO MANUFACTURING ABNORMALITIES WERE NOTED DURING VISUAL INSPECTION. A BATCH REVIEW WAS PERFORMED ON THE ASSOCIATED LOT WITH NO ISSUES NOTED. THERE WAS NOT ENOUGH DATA WITHIN THE COMPLAINT INFORMATION TO IDENTIFY ROOT CAUSE; THEREFORE THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THEREFORE, BAXTER CANNOT DETERMINE THE ROOT CAUSE. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT'S FATHER CONTACTED BAXTER'S CUSTOMER SERVICE TO INFORM THAT 01 UNIT OF THE PRODUCT CODE WAS RECEIVED 03 HOLES ON THE PACKAGE. THE CUSTOMER INFORMED THAT THE SHIPPING PACKAGE HAD A HOLE AS WELL. THE PRODUCT WAS RECEIVED VIA NORMAL POSTAL SERVICE(B)(4). THE PRODUCT WAS NOT USED; THERE WAS NO PATIENT INJURY INVOLVED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H10C03022

    Patients

    Seq Age Sex Outcome Treatment
    1