Model Number 13827 |
Device Problems
Insufficient Flow or Under Infusion (2182); Device Operates Differently Than Expected (2913)
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Patient Problem
No Code Available (3191)
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Event Date 06/04/2018 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint number: (b)(4).Investigation results pending completion of device evaluation.
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Event Description
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It was reported that the volume of undelivered drug remaining in the drug reservoir was greater than the expected volume based upon the programmed infusion rate.The pump was subsequently explanted.
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Manufacturer Narrative
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Internal complaint number: (b)(4).The device evaluation determined that the root cause of the confirmed failure is due to improper storage of the pump.
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Search Alerts/Recalls
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