BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDEHP LS TWN 2CLVE

    MDR report key: 2891187 · Received December 21, 2012

    Report

    Report Number
    9613251-2012-00242
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    January 1, 2012
    Report Date
    November 29, 2012
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K030002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED. A REPRESENTATIVE DEVICE FROM AN UNSPECIFIED LOT 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 A DISCONNECTION. ON AN UNSPECIFIED DATE, THE MALE LUER LOCK ADAPTER OF A PRIMARY TUBING SET WAS CONNECTED TO THE FEMALE ADAPTER OF THE EXTENSION SET. THE OPTION-LOK MALE ADAPTER OF THE EXTENSION SET WAS CONNECTED TO A NEEDLELESS VALVE CAP. THE NEEDLELESS VALVE CAP WAS CONNECTED TO THE PT'S IV ACCESS SITE AND WAS BEING USED TO DELIVER NORMAL SALINE, WITH A VOLUME TO BE INFUSED (VTBI) OF 1000ML, AT A RATE OF 999ML/HR, VIA A PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THAT THE OPTION-LOK MALE ADAPTER OF THE EXTENSION TUBING SET DISCONNECTED FROM THE NEEDLELESS VALVE CAP. IT WAS REPORTED THAT AN UNSPECIFIED VOLUME OF SOLUTION LEAKED FROM THE EXTENSION TUBING SET ONTO THE FLOOR. THE EXTENSION TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NDEHP LS TWN 2CLVE 80FPA FPA HOSPIRA LTD. NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1 CAREFUSION CORPORATION| PRIMARY TUBING SET: REF #2420-0500, MFR CAREFUSION| SMARTSITE NEEDLE-FREE VALVE CAP: REF #200E, MFR| CORPORATION