An inpatient user facility reported a blood leak at the beginning of patient treatment.The arterial line disconnected from the needle hub, which resulted in a blood leak at this location.The line was reconnected, the treatment was terminated and the patient set-up on a different 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 50cc.Bloodlines are available and have been requested for evaluation.
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The complaint device was not returned for analysis; however, companion samples were made available to the manufacturer for physical evaluation.A visual examination performed on the companion samples found the arterial and venous lines to be acceptable.The venous and arterial patient end connectors were examined and no defects were identified; specifically, collar or taper damage.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.One companion sample was then tested using a 2008t hemodialysis machine for simulated use.During the simulated use test, there were no observations of a disconnection or leak from the patient venous and arterial connectors to fistula.The twister was rotated two hours into the test, and no air bubbles occurred in the system.Additionally, no leaks, level variations of venous and arterial chambers, or any alarms were generated during the simulated use testing.The device worked as intended with no noted abnormalities and no defects were identified.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 reported defect of arterial line disconnection was not confirmed.The evaluation of the companion samples confirmed that the devices functioned fully as designed and met specification.
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