Model Number 2426-0500 |
Device Problem
Material Deformation (2976)
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Patient Problems
Cardiac Arrest (1762); Death (1802)
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Event Date 02/04/2020 |
Event Type
Death
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Manufacturer Narrative
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The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
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Event Description
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It was reported that tubing model #2426-0500 failed during a code.A patient was admitted to the emergency department [ed] requiring cpr compressions and was coded multiple times throughout the day.An epinephrine drip infusing at 20mcg/kg/min stopped working after 10 minutes of use and the pump started alarming.The pump was opened and the tubing appeared dilated [ballooning] between the blue connector and the safety clamp.This lead to a 15-20 second delay in care while the tubing was changed out to prime a new epinephrine drip.The epinephrine was infusing through a central line.The patient expired on (b)(6) 2020.The primary cause of death was cardiac arrest and no autopsy will be performed.The medical center stated, "the patient's death was already happening, the event was a tiny piece of that puzzle.It is unlikely the event contributed to the patient's death.".
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Manufacturer Narrative
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The customer¿s report of the silicone segment of the tubing appeared dilated [ballooning] between the upper and lower fitment was confirmed by visual inspection.The set was visually inspected for kinks, incomplete bonding engagements, holes/ tears in the tubing or damages to the components.The balloon was identified to be located just below the upper fitment of the tubing.Further visual inspection under magnification found the walls of the silicone tubing segment to be concentric.Functional testing of previous complaints with the failure mode of ¿balloon/bulge in silicone tubing segment¿ has been performed by injecting an iv push bolus both with and without first clamping the tubing to prevent backflow.Ballooning was not replicated in any clamped testing but has been replicated in unclamped testing when the tubing had been visually observed to be compromised (from previous ballooning).Previously investigated complaints for this same failure mode determined that the ballooning is caused by excess pressure within the silicone tubing segment.The root cause for the source of the excessive pressure is unknown.
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Event Description
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It was reported that a primary tubing failed during a code, and the patient expired.A patient was admitted to the emergency department [ed] requiring cpr compressions and was coded multiple times throughout the day.An epinephrine drip that was infusing via central line at 20mcg/kg/min alarmed and stopped after 10 minutes of use.The pump door was opened and the tubing appeared dilated [ballooning] between the upper and lower fitment, which lead to a 15-20 second delay in care while the tubing was changed and a new epinephrine drip was primed.The patient expired on (b)(6) 2020.The primary cause of death was cardiac arrest and no autopsy was performed.The medical center stated, "the patient's death was already happening, the event was a tiny piece of that puzzle.It is unlikely the event contributed to the patient's death.".
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Search Alerts/Recalls
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