Model Number 4000-100N |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problem
Pain (1994)
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Event Date 03/20/2015 |
Event Type
Injury
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Event Description
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Report stated that a drain was attached to an intercostal catheter on a pt for a tension pneumothorax.The drain was initially swinging and bubbling but after 5 minutes there was no swinging and bubbling causing significant and severe pain and haemodynamic compromise for the pt.Manual aspiration was performed until a second drain was attached.
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Manufacturer Narrative
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We are in the process of performing the investigation and upon completion of the investigation a follow up report will be submitted.
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Manufacturer Narrative
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The drain was received and inspected.There was no indication of any fluids having been collected in the drain or tubing during use.The drain was functionally tested and functioned as designed with air flowing from the open patient line and through the air leak monitor when suction was applied.The drain line was clamped and air flow through the air leak monitor ceased, indicating there are no leaks in the drain or tube set.The suction indicator checkmark was visible in each instance indicating suction applied to the device.Root cause could not be determined.The drain has no failure mode within it that would cause it to cease functioning completely.Once functioning, the unit is mechanically simple enough to continue to function at the same level unless physically damaged in some way (drop/crack) which would be evident to the user.The most likely reason for the drain to become ineffective after being initially effective is a blockage/kink of occlusion in the patient tube or catheter.
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Manufacturer Narrative
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The actual product was not returned therefore a full investigation could not be completed.A device history record review was performed on the possible lot number of the device that was provided in the complaints report.The records indicate that the lot of drains met specifications.There is no mechanism within the drain itself that could become faulty and compromise the function of the device in removing fluids and air from the patient.Once functioning, the unit continues to operate at the same level.The most likely reason for the loss of function was a blockage in the patient tubing caused by clots or a kink and/or blocked/ineffective catheter due to occlusion of the catheter within the pleural space.The subsequent manipulation of the catheter and tubing during manual aspiration and reconnection of the new device may have cleared the blockage and/or the repositioned catheter, causing the second drain to be effective.
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Search Alerts/Recalls
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