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 device has not been returned to animas.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 motor (rewind issue) issue.It was alleged 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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The device has been returned and evaluated by product analysis on 24-jan-2018 with the following findings: a review of the pump¿s black box and alarm history showed no evidence of motor rewind error alarms.During testing, the piston rod was observed to be functioning properly.The original complaint of a piston rod rewind issue was unable to be duplicated.There was no defect found.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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