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) 2016, the reporter contacted animas, alleging a casing/condition (moisture ingress) issue.It was reported that there was moisture ingress in the cartridge compartment.The alleged issue could not be resolved with troubleshooting.There is no indication that the product issue 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: 10/20/2016.Device evaluation: the device has been returned and evaluated by product analysis on 09/28/2016 with the following findings: during visual inspection of the pump, there was no moisture found in cartridge compartment therefore the investigation was unable to confirm the initial complaint alleging this.A leak test was performed and passed therefore no leaks were detected during the investigation.The pump was opened and there was no evidence of moisture internally.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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