Halyard received a single report that referenced three different incidences, which were associated with separate units, involving one patient.This is the first of three reports.Refer to 8030647-2015-00009 for the first report.Refer to 8030647-2015-00010 for the second report.Refer to 8030647-2015-00011 for the third report.It was reported by the caregiver, that the heat moisture exchanger looks and smells different than the previous heat moisture exchanger and has a strong plastic odor that dissipates after it is allowed to air out for a few hours.The plastic also seems thinner.There have been three occurrences in the last two months where the "bars" of the plastic "cage" that surround the sponge have been split or broken apart and has led to a whistling sound as you can hear the air moving through and a decrease in the peak inspiratory pressure which is steady at 38.The caregiver noted a drop to 32 which was corrected after changing out the heat moisture exchanger.The settings are set at 50/14 and there have been no adverse effects or alarms at this setting.The caregiver has used the heat moisture exchanger for a long time and only recently had issues".
|
The device history record for the reported lot number, 2015-02-10, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.One sample device was returned.Prior to decontamination, the sample was assessed for odor.No "plastic" odor was perceived.The flex tubing was cracked in the larger portion that surrounds the hme filter media.The crack occurred between the 4th and 5th segment in this section.The crack extended approximately half way around the diameter of the tubing.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).
|