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Model Number 419102650 |
Device Problems
Free or Unrestricted Flow (2945); Installation-Related Problem (2965)
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Patient Problems
Cardiac Arrest (1762); Death (1802)
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Event Date 06/18/2014 |
Event Type
Death
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Event Description
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On (b)(6) 2014, we received phone call from our us distributor informing a "free-flow" incidence resulted of wrong installation of one of our pumps had occurred, pt passed away, farther detailed info will be submitted asap.On (b)(6) 2014, we had received from our distributor first info (partial) related to the incidence: a nurse in the pacu of the va was supposed to prime the regulator, attach it to the reservoir and then hook up the pt.The ending result was the nurse hooked to reservoir directly up to the catheter.The procedure was a total knee and the catheter was placed in the femoral/groin area for a femoral nerve block.The anesthesiologist confirmed that the pump was mistakenly connected directly to the catheter.The entire reservoir emptied in the pt.The pt eventually went into cardiac arrest and passed away that day.Medical facility: (b)(6).
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Manufacturer Narrative
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Since the device lot yet not reported, we can't trace the mfg date.Eval method: based on the received incidence report.The regulating set includes a flow regulator that controls the administration flow rate.Having the catheter connected directly to the exit port of the reservoirs, tubing will result with free pressurized flow through the catheter.Based on the incidence report, the incidence is resulted of user (authorized medical team member) error.The directions for use are clear on proper assembly of the pain pump.Had the facility followed the direction of use, this event would have been avoided.
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Search Alerts/Recalls
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