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.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.(b)(6).
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Event Description
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On (b)(6) 2016, the reporter contacted animas, alleging a loss of 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 04/25/2016.Device evaluation: the device has been returned and evaluated by product analysis on 04/13/2016 with the following findings: product evaluation was conducted and the alleged complaint could not be duplicated during the testing.The review of the black box data showed one loss of prime warning due to low none-zero force and multiple no delivery, no prime warnings associated with occlusion alarms.During the actual testing, the ez-prime steps were performed correctly with no call service alarm or warning occurrences.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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Search Alerts/Recalls
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