An inpatient user facility reported a blood leak about ten minutes into patient treatment.The venous line disconnected at the hub after the lines were adjusted by a patient care technician, which resulted in a blood leak at this location.The line was reconnected, the treatment was terminated and the patient set-up on the same machine with different bloodlines.The patient then continued treatment and was able to complete therapy successfully.No adverse symptoms or other events occurred and no medical intervention was required.Estimated blood loss was 200cc.Bloodlines are available and have been requested for evaluation.
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The device was returned to the manufacturer for physical evaluation.A visual examination of the returned device was performed; no defects were identified.The device was received with an unknown connector (a non-fmc product) attached to the bloodline.A visual examination of the unknown connector revealed the presence of a crack.A leak test was then performed on the complaint device by pressuring the arterial and venous lines and submerging the device in water.During this test, air bubbles were observed coming from the unknown connector.A second leak test was performed with the return device, but during this test, the unknown connector was removed and replaced to with the recirculation connector (a fmc product).No air bubbles were observed and no leaks were identified.A dimensional analysis of the male conical fittings of the venous and arterial patient connectors was performed; the dimensional checks were within the acceptable range.A records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.The investigation into the cause of the reported problem was not able to confirm the failure mode.The complaint device was received with an unknown connector (a non-fmc product) attached.Although a leak was observed due to the crack in the unknown connector, when the non-fmc product was switched for the proper recirculation connector, the device functioned as intended; no leak observed.Therefore, this complaint has been deemed not confirmed.
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