BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DC BLD Y TYPE PLUM

    MDR report key: 3979816 · Received July 24, 2014

    Report

    Report Number
    9615050-2014-04554
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 2, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K982159
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE WAS RECEIVED FOR INVESTIGATION. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNKNOWN. THE CUSTOMER CONTACT IDENTIFIED ONE POSSIBLE LOT NUMBER (PLOTS). THE CUSTOMER IDENTIFIED THE POSSIBLE LOT NUMBER AS 391005H. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A PINHOLE; SUBSEQUENTLY, A LEAK WAS NOTED. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF PLATELETS, AT AN UNSPECIFIED RATE, VIA A PLUM PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PATIENT'S PARENT NOTED A PUDDLE OF SOLUTION ON THE FLOOR. IT WAS REPORTED THAT THE PARENT DESCRIBED THE PUDDLE AS APPROXIMATELY 3 INCHED IN DIAMETER, ESTIMATED TO BE A LEAK OF BETWEEN 5-10ML. IT WAS REPORTED THAT APPROXIMATELY 5-10ML OF SOLUTION WAS NOTED ON THE FLOOR. THE THERAPY WAS DISCONTINUED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THAT THE PATIENT'S BLOOD WAS DRAWN TO CHECK FOR A HOSPITAL ACQUIRED INFECTION (HAI). THE PATIENT WAS MONITORED FOR SEPSIS AND HAI. NO SPECIFIC DETAILS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE PATIENT'S PLATELET COUNT INCREASED AND THE PATIENT WAS DISCHARGED. DURING VISUAL EXAMINATION OF THE DEVICE AT THE USER FACILITY, WHEN THE BLOOD FILTER WAS SQUEEZED, SOLUTION LEAKED FROM A PINHOLE OF THE FILTER. THE LOCATION OF THE LEAK WAS DESCRIBED AS AT THE 5MM WIDE HEAT FUSED STRIP THAT SEPARATES THE UPPER AND LOWER SECTIONS OF THE FUSED FILTER. THE CUSTOMER CONTACT REPORTED A DELAY OF THERAPY CRITICAL TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435003 DC BLD Y TYPE PLUM 80FRN FRN HOSPIRA COSTA RICA LTD. NA PLOTS5H

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR