BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDEHP 2CLV YSTE MACR

    MDR report key: 2802409 · Received October 18, 2012

    Report

    Report Number
    9613251-2012-00207
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 13, 2012
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT DEVICES WERE DISCARDED. DURING THE INVESTIGATION, NO POSSIBLE CAUSES FOR THE CUSTOMER REPORTED KINKS; SUBSEQUENTLY, THE PATIENTS RECEIVED LESS MEDICATION THAN INTENDED WERE IDENTIFIED. THE DEVICES WERE NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICES COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF THE PATIENTS RECEIVED LESS MEDICATION THAN INTENDED FOLLOWING KINKS IN THE TUBING. ON UNSPECIFIED DATES, THE TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED SEDATION MEDICATIONS IN THE OPERATING ROOM DURING UNSPECIFIED SURGICAL PROCEDURES. AFTER UNSPECIFIED LENGTHS OF TIME AFTER THE PATIENTS WERE POSITIONED FOR THE SURGICAL PROCEDURES, IT WAS REPORTED THAT THE TUBING OF THE TUBING SETS KINKED "WHERE THE TUBING LEAVES THE CLAVE Y-SITES." THE CUSTOMER CONTACT REPORTED THAT, "THE SURGEON COMPLAINED THAT THE PATIENTS STARTED TO WAKE UP BASED ON THE KINKS AND NOT RECEIVING THE NECESSARY MEDICATION. NO SPECIFIC EVENT DETAILS WERE PROVIDED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAYS OF THERAPIES CRITICAL TO THESE PATIENTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NDEHP 2CLV YSTE MACR 80 FPA HOSPIRA LTD. NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK