Additional information: h6 and h10.H10: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.However, the clinical practice described in the reported condition of connection of the patient return line to the catheter using tegos cap is not allowed as per prismaflex operator¿s manual.The user is asked to connect the return line directly to the blood access device, avoiding additional devices between the return line and the blood access device.The use of additional devices (like tegos caps) may compromise the return pressure monitoring, impeding the detection of return disconnections with potential blood loss.The cause of the reported event is a use error.Should additional relevant information become available, a supplemental report will be submitted.
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