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Model Number 21-7324-01 |
Device Problem
Insufficient Flow or Under Infusion (2182)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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Event Date 11/20/2019 |
Event Type
malfunction
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Event Description
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Information was received indicating that at the end of therapy, under infusion was noted on a smiths medical cadd administration set.The reporter indicated that a volume discrepancy of 30-40%, or 30-40ml was noted on a 100ml reservoir while the pump indicated that the reservoir was low or depleted.The reporter also indicated that per customer's email, and event log for the most recent event, customer stated 30-10ml was still left in the reservoir, but the pump reported that 87.35ml used (out of 100ml).Subsequently, the reporter indicated the pump was tested with a standard administration set and found to have excellent accuracy.No adverse effects were reported.
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Manufacturer Narrative
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Additional information: b5, e1, g4, h6.
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Event Description
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Information was received that the incident did occur while in patient use, and that no patient injury resulted. pump was used for labor analgesia, with continuous infusion of pcea and/or pi.The customer tested a pump and observed that it was more accurate delivering a continuous infusion, but noticed inaccuracies with bolus infusions.
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Search Alerts/Recalls
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