BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE

    MDR report key: 2121154 · Received June 13, 2011

    Report

    Report Number
    1423500-2011-07504
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS RECEIVED AND EVALUATED. THIS COMPLAINT FOR A DAMAGED LINE WAS CONFIRMED IN THE LAB. SAMPLE EVALUATION REVEALED A CUT APPROXIMATELY 1/2 INCH BEFORE THE TACK WELD ON THE DRAIN LINE. THE ROOT CAUSE IS UNDETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BAXTER HOMECARE SERVICES REPRESENTATIVE (HCSR) LEFT A VOICE MESSAGE FOR (B)(6) TO RELAY REPORT RECEIVED FROM THE HOME PATIENT'S MOTHER (HPM) THAT TWO CASSETTES IN WHICH A CRACK/SLASH MARK WAS DETECTED "WHERE THE MACHINE CRIMPS IT" IN TUBE ON UNKNOWN DATE(S). NO PATIENT INVOLVEMENT, INJURY OR ADVERSE EVENT IS REPORTED. THIS IS REPORT 1 OF 2. THE CAREGIVER (CG) WAS CONTACTED ON (B)(6) 2011. THE CG STATED THAT THE MARKS LOOKED LIKE LITTLE SLICES IN THE TUBING CLOSEST TO THE CASSETTE. THE CG WAS NOT SURE IF THE LITTLE SLICES HAD PENETRATED THOUGHT THE TUBING, BUT THEY DID NOT WANT TO USE THOSE CASSETTES.

    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 H11A06077

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR