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 leaking system was reported to contribute to the patient not receiving the appropriate fluids.All tubing was changed to address the issue.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: 2183502-2016-02051, 2183502-2016-02052, 2183502-2016-02053, 2183502-2016-02054, 2183502-2016-02055, 2183502-2016-02056, 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 functional testing, a syringe was used to infuse water into the device.During infusion, a leak was observed in the center of the filter and in both unions of the filter and tube.Magnification was used to further inspect the device bonding; evidence of stress and separation of the tube was found.Investigation determined the root cause of the leak was due to mishandling of the device.Mfr# clarification: new registration number (b)(4) ((b)(4)) has been received, however, this initial mdr was filed under the prior registration number (b)(4) ((b)(4)).
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