It was reported that a medex mangum micro fluid delivery system tubing was leaking at the air filter and the bonded tip at the end of the tubing.The leak was observed in a neonatal intensive care unit and the device was in use for less than 24 hours before the leakage was discovered.The tubing was used with a vasopressor and the infant was noted to have decreasing blood pressure.The investigation by the customer revealed that the line that contained the vasopressor was leaking.All tubing was changed to address the issue.The leaking system was reported to contribute to the patient not receiving the appropriate fluids.The patient was a premature infant.The patient continued total parenteral nutrition therapy and drips and remained admitted to the neonatal intensive care unit.No permanent injury was reported.See mfr: 2183502-2016-02052, 2183502-2016-02053, 2183502-2016-02054, 2183502-2016-02055, 2183502-2016-02056, 2183502-2016-02057, 2183502-2016-02058, 2183502-2016-02059, 2183502-2016-02060, and 2183502-2016-02061.
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One used 74" mangum micro fluid delivery system with 0.2 filter was returned for investigation.The sample was received outside of its original packaging.During infusion, a leak was observed at the stopcock site.The bond was inspected microscopically, and a lack of solvent was identified.Investigation determined that the root cause of the leakage was related to a lack of solvent during the bonding process.(b)(4).
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