Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date - unknown due to unknown lot number.The actual device was not returned for evaluation, however, two photographs of the actual sample was provided.Therefore, the investigation was based upon the user facility information and the photographs provided by the user facility.Visual inspection of the photograph revealed the presence of blood adhering to the blood outlet port near the blood cardioplegia port.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.Ifu states: do not use an oxygenator and reservoir that leaks.Replace it with another capiox rx15 oxygenator and reservoir.Recirculate the priming solution at a rate of 4l/min or higher to facilitate air removal.Failure to remove air from the oxygenator may result in serious injury to the patient.Band all connections in the circuit.Ensure that all connected parts including the luer caps, the lock adapters and the port caps are securely affixed.Loose connections may cause contamination or a blood leak.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, it is likely that the red cap had not been attached to the blood cardioplegia port firmly, and/or the tube had not jointed to the blood cardioplegia port firmly, where blood leaked; or the tube had not been jointed to the blood outlet port firmly, where blood leaked.However, with no return of the actual sample to evaluate, the exact cause for the reported event cannot be definitively determined based on the available information.(b)(4).
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