Device Problems
Partial Blockage (1065); Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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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.(b)(6).
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Event Description
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On (b)(6) 2017, the reporter contacted animas, alleging a occlusion (frequent/persistent) 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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Device evaluation: the device has been returned and evaluated by product analysis on 06/15/2017 with the following findings: a review of the black box showed multiple call service occlusion alarms due to a high force.The battery cap fit securely.The rewind, load, and prime steps were performed successfully.The pump was opened to find no intermittent conditions internally.No alarms or occlusions occurred during the investigation.Unrelated to the original complaint, the battery compartment was cracked below the grip pad.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.(b)(4).
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Search Alerts/Recalls
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