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.
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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.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 05/06/2016.Device evaluation: the device has been returned and evaluated by product analysis on 04/26/2016 with the following findings: a review of the pump¿s black box revealed loss of primes with several cs 162 due to low non zero force.The ez-prime steps were performed correctly.There was no cs 162 alarm duplicated during investigation.The product performed within specification.Unrelated to the original complaint, the battery compartment was observed to be cracked.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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