BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2-L HUB CONNECT ASSY REPLACEMENT SET

    MDR report key: 2491796 · Received March 9, 2012

    Report

    Report Number
    1036844-2012-00072
    Event Type
    Malfunction
    Date Received
    March 9, 2012
    Date of Event
    February 29, 2012
    Report Date
    March 8, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    NFK
    PMA / PMN Number
    K020430
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE CATHETER REPAIR KIT WAS BEING USED ON A (B)(6) MALE PATIENT IN THE DIALYSIS UNIT WITH A MEDICAL HISTORY OF DIABETES, HYPERTENSION, AND CHRONIC RENAL FAILURE. AFRICA WAS TELEPHONICALLY INFORMED THAT THIS SAME PATIENT AGAIN DEVELOPED A LEAKAGE OF BLOOD FROM THE VENOUS (BLUE) PORT DURING HEMODIALYSIS. THE LEAKAGE WAS SMALL ENOUGH FOR THE HEMODIALYSIS TO BE CONTINUED VIA EXISTING HUBS. THE PATIENT WILL HAVE TO HAVE A REPLACEMENT OF THE HUB ASSEMBLY BEFORE THE NEXT HEMODIALYSIS SESSION. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2-L HUB CONNECT ASSY REPLACEMENT SET CHRONIC HEMODIALYSIS CATHETER PRODUCTS NFK ARROW INTL., INC. RF1082462

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR