The actual device was returned to the manufacturing facility for evaluation.Visual inspection upon receipt confirmed the customer's observation.The sampling line tube had been fractured at the joint of the oxygenator blood outlet port.The sampling line tube was cut out vertically into a piece for dimensional inspection.The inside and outside diameters were confirmed to meet manufacturing specification.Magnifying and electron microscopic inspection of the fracture cross-sections found some segments were in a smooth state and other segments in a rough state.Simulation testing was conducted.The state of the fracture on the actual sample is experientially known to be consistent with the state when the tube has been damaged as a result of exposition to a shock force under a cold temperature.The reproductive tests were conducted on the current product sample as follows.The sampling line tube of a current product sample was exposed to a shock force at the joint of the tube and the oxygenator outlet port after having been left under a low temperature for 12 hours.The sampling line tube became fractured at the joint.Electron microscopic inspection of the fracture cross-section found that the state of the surface was very similar to that of the actual sample.A review of the device history records and product release decision control sheet of the involved product code/lot # combination was conducted with no relevant findings.A search of the complaint file found one other report with the involved product code/lot# combination.See mdr 9681834-2017-00017 for details.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause of the reported event cannot be definitively determined based on the available information, it is likely that the actual sample was subjected to a shock force after having been left at a low temperature, resulting in the reported breakage of the tube.The device labeling does address the potential for such an event in the instruction for use (ifu) with the statement such as the following: "do not use if the package or device is damaged (e.G.Cracked) or any of the part caps are off." (b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
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