Patient with dignity 5f port on the right arm undergoing treatment with anticancer chemotherapy.As extravasation due to catheter injury is suspected, the device is removed and a partial catheter injury is found, approximately 6-7cm form the connection between reservoir and catheter.
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An investigation has been initiated.Currently waiting for the device to be returned for evaluation.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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The dignity port was returned for evaluation with the lock and lumen still attached.A functional test was performed, and the complaint was confirmed.A small leak was noted in the lumen between the 27 and 28 cm marks.Under magnification the lumen appears to have been pinched at the location of the leak.No lot number was provided.Without a lot number a review of the manufacture records is not possible.The device was in use for more than 3 1/2 years with no reported issues.A definitive root cause cannot be determined but is not likely manufacture related.Potential causes for lumen leaks include excessive pressure, i.E flushing/infusion against resistance, and pinch off.The instructions for use (ifu) contain the following warnings, precautions, and statements: do not power inject through a port system that exhibits signs of clavicle-first rib compression or pinch-off as it may result in port system failure.Do not use a syringe smaller than 10ml.Prolonged infusion pressure greater than 25 psi may cause damage to a patient's vessels or viscus.Failure to ensure patency of the catheter prior to power injection studies may result in port system failure.Power injector machine pressure limiting feature may not prevent over pressurization of an occluded catheter.Exceeding the maximum flow rate may result in port system failure and/or catheter tip displacement.Do not exceed a 325-psi pressure limit setting, or the maximum flow rate setting on the power injection machine, if power injecting through the power injectable implantable infusion port device.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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