BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLD Y-TYPE 105 OL NV

    MDR report key: 1993792 · Received January 13, 2011

    Report

    Report Number
    9615050-2011-00020
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 17, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICES WERE DISCARDED. 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 INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF SEPARATIONS. THE TUBING SETS WERE BEING USED TO DELIVER AUTOLOGOUS PT BLOOD THAT HAD BEEN COLLECTED DURING UNSPECIFIED OPEN HEART SURGICAL PROCEDURES. AFTER THE PT'S BLOOD WAS CLEANED AND PROCESSED, THE BLOOD WAS PLACED INTO 60ML BLOOD BAGS. THE BLOOD BAGS WERE SPIKED WITH THE TUBING SET. THE BLOOD BAGS WERE THEN PRESSURIZED TO 250MMHG VIA PRESSURE BAGS. AFTER UNSPECIFIED LENGTHS OF TIME IN USE, THE TUBINGS SEPARATED FROM THE SPIKES OF THE TUBING SETS. THE COLLECTED BLOOD SPILLED ONTO THE OPERATING ROOM FLOORS AND WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. THE TUBING SETS WERE REPLACED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAYS OF THERAPIES CRITICAL TO THESE PTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO 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 900795H

    Patients

    Seq Age Sex Outcome Treatment
    1 600ML BLOOD BAG, LIST #T3106, MANUFACTURED BY| CHARTER MEDICAL LTD.