BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASBLOOD SECONDARY SET

    MDR report key: 3172425 · Received June 5, 2013

    Report

    Report Number
    9615050-2013-01525
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    April 1, 2013
    Report Date
    May 10, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. 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 DISCONNECTION. ON AN UNSPECIFIED DATE, AN UNSPECIFIED PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION, AT AN UNSPECIFIED RATE, VIA A PUMP. AT AN UNSPECIFIED TIME, THE SECURE LOCK MALE ADAPTER OF THE SECONDARY TUBING SET WAS CONNECTED TO A FEMALE TUBING SET FOR A PIGGYBACK DELIVERY OF AN UNSPECIFIED VOLUME OF BLOOD BANK BLOOD. IT WAS REPORTED THAT AFTER THE SECONDARY DELIVERY WAS STARTED, THE SECURE LOCK MALE ADAPTER OF THE SECONDARY TUBING SET DISCONNECTED FROM THE FEMALE ADAPTER OF THE PRIMARY TUBING SET. IT WAS REPORTED THAT 30ML OF BLOOD LEAKED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED, INCLUDING IF THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249355 CASBLOOD SECONDARY SET 80FPA FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR UNSPECIFIED PRIMARY TUBING SET, LIST# UNK,| LOT# UNK