Device Problem
Retraction Problem (1536)
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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.
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Event Description
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On (b)(6) 2019, the reporter contacted animas, alleging a motor (rewind issue) issue.It was reported that the rewind stops prior to completion.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the issue may result in an inability to use the product which may lead to long term cessation of delivery.
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Manufacturer Narrative
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Device evaluation: the pump has been returned and evaluated by product analysis on 30-oct-2019 with the following findings: a review of the pump¿s black box showed cs 078 motor rewind alarm.During testing, a cs 078 alarm occurred during the rewind step.The pump was opened and an internal moisture found on the motor flex connector and surrounding components.A crack in the battery compartment was observed.Leak testing revealed a leak at the battery compartment.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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