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) 2016, the reporter contacted animas, alleging that the piston rod was not fully retracting.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 01/03/2017 device evaluation: the device has been returned and evaluated by product analysis on 12/22/2016 with the following findings: during investigation, an intermittent load step malfunction was duplicated.The pump was exercised for 24 hours; it was unable to detect the cartridge and the force calibration failed at 00 force.The pump was opened to investigate and a crack was found on the force sensor flex at the pin.(b)(4).
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Search Alerts/Recalls
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