BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDEHP MACRO 30IN EXT

    MDR report key: 4210822 · Received August 1, 2014

    Report

    Report Number
    9613251-2014-00124
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 13, 2014
    Report Date
    July 16, 2014
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 THE TUBING SET BURST; SUBSEQUENTLY, A LEAK WAS NOTED. IT WAS REPORTED THAT A BLOOD TUBING SET WAS CONNECTED TO THE FEMALE LUER LOCK OF THE EXTENSION SET AND THE OPTION-LOK MALE ADAPTER OF THE EXTENSION SET WAS CONNECTED TO AN UNSPECIFIED DEVICE AND WAS BEING USED TO DELIVER AN UNSPECIFIED MED. IT WAS REPORTED THAT ONE HOUR AFTER THE DELIVERY WAS STARTED, IT WAS REPORTED THAT DURING A CT SCAN, AN UNSPECIFIED VOLUME OF IV CONTRAST DYE WAS INJECTED INTO THE EXTENSION SET, AT AN UNSPECIFIED RATE, VIA AN UNSPECIFIED ROUTE. AFTER AN UNSPECIFIED LENGTH OF TIME DURING THE INJECTION, THE EXTENSION SET BURST. NO SPECIFIC DETAILS WERE PROVIDED. IT WAS REPORTED THAT THE AN UNSPECIFIED VOLUME OF THE PT'S IV FLUID LEAKED ONTO THE FLOOR AND ONTO THE PT. THE CUSTOMER CONTACT REPORTED THAT THE TUBING SET HAD BEEN IN USE FOR LESS THAN HOUR WHEN THE EVENT OCCURRED. THE TUBING SET WAS REPLACED. IT IS UNK IF THE CT SCAN WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTION WAS REQUIRED. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451941 NDEHP MACRO 30IN EXT 80FPA FPA HOSPIRA LTD. NA 31236NS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MICRON Y-TYPE BLOOD SET, WITH HAND PUMP| FILTER CAP, LIST # UNK, LOT # 2804003, MFR ICU MED| 2 CLAVE WITH ROTATING LUER