Device Problem
Moisture Damage (1405)
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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) 2017, the reporter contacted animas, alleging a casing/condition (moisture ingress) issue.It was alleged that the battery compartment had moisture corrosion.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the alleged malfunction has the ability to result in a delay in treatment or long term cessation in delivery if the damage impacts the power circuit or cartridge compartment.
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Manufacturer Narrative
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Follow-up #1: date of submission 12-feb-2018.Device evaluation: the device has been returned and evaluated by product analysis on 26-jan-2018 with the following findings: during investigation, corrosion was found in the battery compartment, with a leak.The battery compartment was cracked on the side at the threads and cracked below the bumper pad.The pump cover was removed to find no further evidence of moisture damage.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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