Device Problem
Failure to Prime (1492)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The pump has not been returned to animas for evaluation.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.No conclusions can be made at this time.Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.
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Event Description
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On (b)(6) 2016, the reporter contacted animas, alleging a prime (unable to prime) issue.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no indication that the product caused or contributed to an adverse event.
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Manufacturer Narrative
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Follow-up #1 date of submission 04/19/2016-product analysis: the device was returned and evaluated by product analysis on 04/13/2016 with the following findings: the complaint could not be duplicated with investigation.Review of the pump¿s black box revealed multiple loss of prime warnings.The pump successfully completed a prime sequence, bolus deliveries, and 24-hour exercise test without issue or alarm.The pump¿s force sensor was found to be within specification.
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Search Alerts/Recalls
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