BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASBLOOD SECONDARY SETS

    MDR report key: 3172409 · Received June 5, 2013

    Report

    Report Number
    9615050-2013-01524
    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
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICES WERE DISCARDED. 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

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF DISCONNECTIONS. ON UNSPECIFIED DATED, UNSPECIFIED PRIMARY TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED MEDICATIONS, AT UNSPECIFIED RATES, VIA PUMPS. AT UNSPECIFIED LENGTHS OF TIME, THE SECURE LOCK MALE ADAPTERS OF THE SECONDARY TUBING SETS WERE CONNECTED TO FEMALE ADAPTERS AT UNSPECIFIED LOCATIONS ON THE PRIMARY TUBING SETS FOR PIGGYBACK DELIVERIES OF UNSPECIFIED VOLUMES OF UNSPECIFIED BLOOD PRODUCTS. THE CUSTOMER CONTACT REPORTED THAT AFTER THE SECONDARY DELIVERIES WERE STARTED, THE SECURE LOCKS DISCONNECTED FROM THE FEMALE ADAPTERS OF THE PRIMARY TUBING SETS. IT WAS REPORTED THAT UNSPECIFIED VOLUMES OF BLOOD PRODUCTS LEAKED. 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 ADDITIONAL INFORMATION WAS PROVIDED, INCLUDING IF THE TUBING SETS WERE REPLACED AND THE THERAPIES RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249518 CASBLOOD SECONDARY SETS 80FPA FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED PRIMARY TUBING SETS, LIST#UNK,LOT #UNK