Model Number AP03000H |
Device Problems
Infusion or Flow Problem (2964); No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/13/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned to intera oncology on (b)(6) 2022 and evaluated under a testing protocol.The preliminary results demonstrate that the device was able to be prepped and flowed accordingly within manufacturing specification.The complaint could not be reproduced and therefore could not be confirmed via the device evaluation.The device history record was reviewed and there were no deviations or nonconformances pertaining to this device, all specifications were met at the time of manufacture.A supplemental mdr will be filed upon final results of the testing.Blank spaces in the mdr form represent unknown information at the time of this filing.If further information is received at a later date, a supplemental report will be filed.
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Event Description
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It was reported by a healthcare provider that an intera 3000 hepatic artery infusion pump was prepped with the required steps.The clinician reported that the pump would not bead during prep as expected.The clinician increased the temperature of solution warmer from 95f up to 120f to attempt to increase the flow.They used low dose heparinized saline to flush the catheter, decreased temperature to 95 f, and waited 10 minutes and pump did not bead.The temperature of the solution warmer was increased back up to 120 f, then they emptied the pump, injected 5 ml of saline in, 1 ml returned at a significantly slow rate.The surgeon ultimately decided to use a new pump in place of this pump.A new pump was opened, prepped, and implanted.No patient injury was reported.
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Manufacturer Narrative
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The testing to evaluate the device was completed and the final results demonstrated that the device was able to be prepped and flowed accordingly within manufacturing specification.The complaint could not be reproduced and therefore could not be confirmed via the device evaluation.
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Event Description
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It was reported by a healthcare provider that an intera 3000 hepatic artery infusion pump was prepped with the required steps.The clinician reported that the pump would not bead during prep as expected.The clinician increased the temperature of solution warmer from 95f up to 120f to attempt to increase the flow.They used low dose heparinized saline to flush the catheter, decreased temperature to 95 f, and waited 10 minutes and pump did not bead.The temperature of the solution warmer was increased back up to 120 f, then they emptied the pump, injected 5 ml of saline in, 1 ml returned at a significantly slow rate.The surgeon ultimately decided to use a new pump in place of this pump.A new pump was opened, prepped, and implanted.No patient injury was reported.
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Search Alerts/Recalls
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