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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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.Unrelated to the original complaint, it was observed that the bolus button cover was torn but the bolus button was still operable during the investigation.The battery cap and cartridge cap were not returned with the pump and test caps were used to complete the investigation.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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