BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLD Y-TYPE 105 OL NV

    MDR report key: 1621131 · Received March 1, 2010

    Report

    Report Number
    9615050-2010-00028
    Event Type
    Malfunction
    Date Received
    March 1, 2010
    Date of Event
    February 1, 2010
    Report Date
    February 8, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    KDC
    PMA / PMN Number
    K780880
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICES WERE DISCARDED. A REPRESENTATIVE DEVICE FROM THE SAME LOT WAS RECEIVED. INVESTIGATION IS NOT COMPLETED. (B) (4). (B) (4).

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF DIFFICULTY REGULATING FLOW. THE TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED BLOOD PRODUCTS VIA GRAVITY. THE CAIR CLAMPS WERE BEING USED TO REGULATE THE FLOW. AFTER UNSPECIFIED LENGTHS OF TIME IN USE, THE CUSTOMER CONTACT REPORTED NO FLOW OR UNRESTRICTED FLOW WAS NOTED. IT WAS REPORTED THAT DURING THE NO FLOW CONDITION, KINKS WERE NOTED TO HAVE FORMED IN THE TUBINGS WHERE THE CAIR CLAMPS HAD BEEN CLOSED. THE NURSES REPORTED THAT ROUTINELY, THE CAIR CLAMPS ARE MOVED ON THE TUBING SETS TO AVOID KINKING. THE NURSES MANIPULATED THE KINKED TUBING SECTIONS TO RESUME FLOW. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO DELAYS IN THERAPY CRITICAL FOR THE PTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLD Y-TYPE 105 OL NV 79KDC KDC HOSPIRA COSTA RICA LTD. NA 790615H

    Patients

    Seq Age Sex Outcome Treatment
    1