Catalog Number MX9341L |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
Blood Loss (2597)
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Event Date 02/22/2015 |
Event Type
Injury
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Event Description
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User facility reported while performing extracorporeal membrane oxygenation (ecmo) in the neonatal intensive care unit (nicu), the listed device was in use when the stopcock came apart at the handle and air entered the circuit.The "faulty products" were replaced to remedy the issue.Some blood loss occurred, but it is unknown how much.No permanent patient harm occurred.
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Manufacturer Narrative
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Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
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Manufacturer Narrative
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One used product sample was returned for product investigation.The stopcock handle (also known as plug) was disconnected from the stopcock body, causing the device to be non-functional.Visual inspection revealed no moulding issues with the stopcock handle or body.The handle was reassembled on to the stopcock body and tensile tested.The handle disconnected from the stopcock body only after 25.065 lbs and 23.852 lbs of force was applied to it.Specification requires the handle to remain seated on the stopcock body up to 12.1lbs of applied force.Therefore, the returned product sample was found to pass specifications for tensile testing.As the returned product sample was returned disassembled, the reported product fault was confirmed; once reassembled the returned sample met specifications and was found to perform as intended.
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Search Alerts/Recalls
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