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.(b)(6).
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Event Description
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On (b)(6) 2019, the reporter contacted animas alleging that the piston rod was not retracting.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 device has been returned and evaluated by product analysis on 12-jun-2019 with the following findings: a review of the black box showed call service 064 alarms.The piston did not move during the rewind step.The pump gave a call service 064 alarm during the load step.The pump was opened, and the motor would not move when connected to an external power supply.
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Search Alerts/Recalls
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