BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM COMBI SET

    MDR report key: 725119 · Received June 12, 2006

    Report

    Report Number
    8030665-2006-00182
    Event Type
    Malfunction
    Date Received
    June 12, 2006
    Date of Event
    May 10, 2006
    Report Date
    June 8, 2006
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FJK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SECTION F: (3) FMS ABBEVILLE, 904 JOHN M HARDY DRIVE, ABBEVILLE, LA, 70510, (4) ENA DARBY, RN, (5) 337-893-7577, (6) 05/10/2006, (7) INITIAL, (8) 06/08/2006, (9) 2 MONTHS, (10) PATIENT CODE: 2199, DEVICE CODE: 1562, (11) NO, (12) DIALYSIS FACILITY, (13) YES. 05/12/2006, (14 REYNOSA MANUFACTURING, FRESENIUS MEDICAL CARE, NA, 9004 TRAVIS DRIVE, PHARR, TX, 78577.

    Description of Event or Problem · 1

    RECEIVED AN ELECTRONIC REPORT FROM A HEMODIALYSIS FACILITY. THE EVENT REPORTED THAT THE PATIENT HAS JUST BEGUN THEIR HEMODIALYSIS TREATMENT WHEN THE SALINE SIDE ARM OF THE BLOODLINE TUBING SEPARATED FROM THE BLOOD LINE. THERE WAS NO REPORT OF PATIENT INJURY. THE LINES NEVER FILLED ENTIRELY WITH THE PATIENT'S BLOOD. THE DIALYSIS TREATMENT WAS TOPPED AND NEW BLOODLINES WERE SET UP AND THE TREATMENT WAS COMPLETED AS PRESCRIBED. THE PATIENT DID HAVE A 50 ML BLOOD LOSS BUT HAS NOT HAD ANY ILL EFFECT. THE PATIENT WAS DISCHARGED TO HOME AT THE END OF THEIR THERAPY. A SAMPLE IS AVAILABLE FOR AN EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM COMBI SET HEMODIALYSIS BLOODLINES FJK REYNOSA MANUFACTURING NA 6CR104

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR