BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM Y-BLOOD SET W/FLR CLAVE 110IN NDEHP

    MDR report key: 2852527 · Received November 15, 2012

    Report

    Report Number
    9615050-2012-01343
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 23, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K103224
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE 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

    THE CUSTOMER REPORTED A DELAY IN CRITICAL THERAPY FOLLOWING A LEAK. THE PATIENT WAS BEING TREATED IN THE EMERGENCY DEPARTMENT FOR A HEMOGLOBIN OF LESS THAN 7GM/DL. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF PACKED RED BLOOD CELLS (PRBCS), AT UN UNSPECIFIED RATE, FOR A DURATION OF 1 HOUR, VIA A PLUM PUMP. IT WAS REPORTED THAT THE SECURE LOCK MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO THE PATIENT'S IV ACCESS SITE. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THAT THE NURSE NOTED THAT AN UNSPECIFIED VOLUME OF BLOOD WAS LEAKING FROM THE CONNECTION SITE OF THE TUBING AND THE SECURE LOCK MALE ADAPTER. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM Y-BLOOD SET W/FLR CLAVE 110IN NDEHP 80FPA FPA HOSPIRA COSTA RICA LTD. NA 090515H

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR