Model Number 8015 |
Device Problem
Excess Flow or Over-Infusion (1311)
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Patient Problems
Pain (1994); Swelling (2091); No Code Available (3191)
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Event Date 07/03/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Admitting diagnosis: lumbar laminectomy.Race/ethnicity: unknown per customer.
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Event Description
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It was reported the iv pump was programmed at a rate of 200ml/hr to infuse vancomycin 200ml.The infusion was started on (b)(6) 2019 at 1214 and stopped at 1238 due to patient compliant of arm swelling and pain.The infusion report shows that only a volume of 36.2ml was infused during those 24 minutes, however the iv bag was found to be empty.The event resulted to iv site infiltration that required heat and elevation.
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Event Description
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It was reported the iv pump was programmed at a rate of 200ml/hr to infuse vancomycin 200ml.The infusion was started on (b)(6) 2019 at 1214 and stopped at 1238 due to patient compliant of arm swelling and pain.The infusion report shows that only a volume of 36.2ml was infused during those 24 minutes, however the iv bag was found to be empty.The event resulted to iv site infiltration that required heat and elevation.On-site findings-during an onsite visit, no irregularities were observed during the visual inspection or on the device logs.The asm rate accuracy testing found the device within specification (2.75% error).Received a copy of a medwatch which states, "free flow/ overinfusion fda safety report id# (b) (4)".Received a copy of a medwatch which states, "suspected free flow event fda safety report id # (b)(4)".
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Manufacturer Narrative
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The suspect has changed from an instrument (device) to a disposable set.Supplemental 322170 and initial emdr 314645 were initiated for the pcu device (8015), not the set.Reference the new manufacturer report # 9616066-2019-02861 from emdr 326904.
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Manufacturer Narrative
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The customer¿s concerns for an infusion of vancomycin 200ml where the infusion report shows 36.2ml hand infused in 24 minutes, however the bag was found empty was not confirmed in the logs; however, during testing of the administration and secondary sets fluid was observed back flow into the primary administration set was observed.There were no obvious programming errors observed in the pcu event log.Timed rate accuracy testing performed on the source pump module found the device operating in specification.During testing of the administration set, back flow was observed.Back flow into the primary iv bag can give the impression that an infusion completed sooner than expected.Inspection of the pumping mechanism found no irregularities.The root cause of the cause of the customer's report could not be confirmed.
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Event Description
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It was reported the iv pump was programmed at a rate of 200ml/hr to infuse vancomycin 200ml.The infusion was started on (b)(6), 2019 at 1214 and stopped at 1238 due to patient compliant of arm swelling and pain.The infusion report shows that only a volume of 36.2ml was infused during those 24 minutes, however the iv bag was found to be empty.The patient experienced pain and swelling.The event resulted to iv site infiltration that required heat and elevation.On-site findings-during an onsite visit, no irregularities were observed during the visual inspection or on the device logs.The asm rate accuracy testing found the device within specification (2.75% error).Received a copy of a medwatch which states, "free flow/ overinfusion fda safety report id# (b) (4)".Received a copy of a medwatch which states, "suspected free flow event fda safety report id # (b)(4)".
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Search Alerts/Recalls
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