Catalog Number 21-6300-02 |
Device Problem
Excess Flow or Over-Infusion (1311)
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Patient Problem
Overdose (1988)
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Event Date 10/07/2016 |
Event Type
Injury
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Manufacturer Narrative
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Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.(b)(4).
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Event Description
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It was reported that a cadd-legacy pca pump was involved in an oxynorm overinfusion incident.The infusion was programmed for 6 days but was observed that the cassette (100ml) was empty and infused into the patient after 48 hours.Troubleshooting involved testing the infusion system without patient involvement and showed that the system infused 3 times more than the programmed volume.The infusion system was tested with different cassettes and it was noted that the problem stopped.The cassette involved in the incident was retested without patient involvement and the observed incident did not occur again.Intravenous narcan was administered to decrease the oxynorm overinfusion effects.No permanent injury was reported.See mfr: 3012307300-2016-00360.
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Manufacturer Narrative
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One cadd-legacy® pca pump was returned for investigation.Visual inspection of the returned device found it to be in good condition.A review of the device event history log found that the device had delivered the volumes of medication as programmed by the clinician.Functional accuracy sensor testing were performed on the device.No discrepancies were found during testing and the device was found to be within specification for delivery accuracy and alarm sensors.Investigation did not find fault with the returned device and determined that it functioned as designed.
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Event Description
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It was further reported that the device was in use starting on (b)(6) 2016 and the reported event was observed on (b)(6) 2016.Additionally it was reported that the device was programmed at a rate of 0.1 ml/h with an allowed bolus rate of 0.25ml.
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Search Alerts/Recalls
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