Device Problem
Failure to Prime (1492)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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) 2016, the reporter contacted animas, alleging a prime (loss of prime) issue.It was reported that the loss of prime occurred 3 or more times.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 5/26/2016 device evaluation: the device has been returned and evaluated by product analysis on 5/13/2016 with the following findings: there were multiple loss of prime alarm warnings observed in the black box history associated with low non-zero force.The pump was exercised for 24 hours and the loss of prime issue was not duplicated.The force calibration passed within specification.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.(b)(4).
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Search Alerts/Recalls
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