BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1911995 · Received December 1, 2010

    Report

    Report Number
    1423500-2010-06423
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 7, 2010
    Report Date
    November 7, 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 SAMPLE WAS DISCARDED. A BATCH REVIEW WILL BE PERFORMED FOR THE LOT NUMBER PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4).A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH EXCEPTION ISSUES NOTED DURING THE MANUFACTURING PROCESS FOR KINKS WALLS NOT TOUCHING. QUALITY RE-INSPECTION WAS ACCEPTABLE. ROOT CAUSE WAS PERSONNEL. PERSONNEL WAS RE-INSTRUCTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A LEAK FOUND DURING PRIME. THIS COMPLAINT WAS NOT CONFIRMED AND NO ROOT CAUSE WAS DETERMINED BECAUSE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) CONTACTED (B)(6) TO REPORT WATER ON THE FLOOR DURING USE OF A HOMECHOICE (HC) MACHINE DURING PRIME. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO START OVER USING NEW SUPPLIES AND CONTACT THE PERITONEAL DIALYSIS REGISTERED NURSE (PD RN). THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. ON (B)(6) 2010 PRODUCT SURVEILLANCE SPOKE WITH THE HP WHO CONFIRMED THE LEAK ACTUALLY OCCURRED "AT THE CASSETTE". THE HP ADVISED THAT EVERYTHING WAS FINE. THERE WAS NO INJURY OR REPORTED SYMPTOMS AS A RESULT OF THIS INCIDENT. THE HP ADVISED THAT SHE HAS BEEN CONTINUING HER THERAPY AND USING HER SUPPLIES WITH NO SIMILAR ISSUES.

    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 H10G24029

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR