Fill volume: 350ml.Flow rate: 100ml/hr.Procedure: unk.Cathplace: unk.Please reference: 2026095-2014-00292/(b)(4).Device 2 of 2: an international distributor reported that 2 incidents of fast flow occurred.It was reported as, "pump disconnected by the nurse 30 min after the beginning of the infusion, according to the nurse, the flow was to high".It was reported that the pumps were used directly after filling.No patient injury or medical intervention was reported.The device is available for return and analysis.Additional information was requested, but is not available at this time.Infusion start time: (b)(6) 2014 at 09:30am.Infusion end time: (b)(6) 2014 at 10:00 am.
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Method: a partially full device was received for analysis.At this time, clarification on the device is being requested from the reporter.In addition, a review of the device history record (dhr) was performed.Results: there are no testing results available as the investigation and evaluation are currently in progress.Conclusions: once the analysis and investigation are completed a follow-up report will be submitted.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.
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