BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDISYSTEMS HEMODIALYSIS BLOOD TUBING SET

    MDR report key: 2090931 · Received May 3, 2011

    Report

    Report Number
    2919260-2011-00001
    Event Type
    Death
    Date Received
    May 3, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 4, 2011
    Manufacturer
    MEDISYSTEMS CORPORATION, A NXSTAGE COMPANY
    Product Code
    FJK
    PMA / PMN Number
    K080807
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLOODLINE IN USE AND THE CATHETER CONNECTORS WERE RETURNED TO THIS MANUFACTURER FOR EVALUATION. BOTH ITEMS WERE VISUALLY AND MICROSCOPICALLY INSPECTED AND FOUND TO BE FREE OF DEFECTS. BOTH CONNECTORS MET LUER TAPER SPECIFICATIONS PER (B)(4). THE PRODUCTS WERE SECURELY CONNECTED TOGETHER WHEN FIRST RECEIVED AND FURTHER TESTING SHOWED THAT A SECURE CONNECTION COULD BE OBTAINED. REVIEW OF MANUFACTURING RECORDS FOR THE FINISHED BLOOD TUBING SET AND FOR THE VENOUS CONNECTOR COMPONENT SHOWED THAT THE PRODUCT MEETS ALL DESIGN, QUALITY, AND PRODUCT RELEASE SPECIFICATIONS. MEDISYSTEMS CORPORATION CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTS ONE EVENT IN WHICH THE (B)(6) PT'S VENOUS CATHETER PORT SEPARATED FROM THE DIALYSIS BLOOD TUBING SET CONNECTOR APPROX ONE HOUR INTO THERAPY. THE PT'S ACCESS DEVICE WAS COVERED WITH 3 BLANKETS AND WAS NOT VISIBLE TO STAFF PER INSTRUCTIONS FOR USE WARNING AND FACILITY'S INTERNAL PROCEDURE. STAFF RESPONDED TO A DROP IN BP AND FOUND PT WITH CATHETER ACCESS SEPARATED AND BLOOD LEAKING INTO THE BLANKETS. PT WAS UNCONSCIOUS AND SUBSEQUENTLY EXPIRED. FACILITY REPORTED EBL BETWEEN 150ML AND 1000ML. INITIAL INTERNAL INVESTIGATION, PERFORMED BY FACILITY BIOMEDICAL STAFF, INDICATED NO VISIBLE DEFECTS ON THE BLOODLINE OR CATHETER CONNECTORS. A SECURE CONNECTION WAS SUCCESSFULLY ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDISYSTEMS HEMODIALYSIS BLOOD TUBING SET HEMODIALYSIS BLOOD TUBING SET FJK MEDISYSTEMS CORPORATION, A NXSTAGE COMPANY NA 0085118

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death (B)(4)| ALTAIR DUAL LUMEN RIGHT SIDE SUBCLAVIAN CATHETER| (B)(4) 2008K HEMODIALYSIS MACHINE: #H0102,