Intended Use Statement
V4.1 of BloodTrack Manager is included in the BloodTrack 510(k):
BloodTrack is an electronic information management system intended for use in healthcare facilities by trained healthcare professionals to help prevent latent errors by monitoring the handling, transportation and transfusion of blood or blood products so that complete audit trails are recorded.
BloodTrack can enhance transfusion safety by providing for positive patient identification at the bedside when blood samples are collected and at the time of transfusion of blood or blood products.
BloodTrack can also reduce the risk of a healthcare professional retrieving the wrong blood unit for a patient by printing a blood product pickup slip at the bedside and requiring confirmation of the patient’s identification when blood units are removed from a managed storage location to be delivered to the patient’s bedside. Each time a blood unit is removed from, or placed into, a managed storage location, BloodTrack verifies the expiration date of the blood unit, that the audit trail for the blood unit is complete, and that the blood unit has not been out of refrigeration too long. If the blood unit has expired, the audit trail is incomplete, or the blood unit has been out of refrigeration too long, BloodTrack warns the user of the problem.
BloodTrack can control remote release, a process where a compatibility label is remotely printed and applied to a blood unit outside of the blood bank. Remote release involves the use of an inventory of unassigned blood units maintained in BloodTrack managed storage locations outside of the blood bank. When blood is needed for a patient, BloodTrack verifies the patient’s eligibility for remote release by querying the Blood Establishment Computer System (BECS) and if eligible, prints a compatibility label to be applied to the blood unit at the managed storage location. Although the compatibility label may be printed remotely by BloodTrack, the decision to print the compatibility label is still made by the BECS. In simple terms, the BloodTrack remote release process simply changes the location where the compatibility label is printed and applied to the blood unit.
BloodTrack can prompt the user at each stage of the transfusion process to scan patient identification, blood unit or compatibility barcode labels, enter patient vital signs, confirm special blood requirements, record volume transfused, or indicate transfusion reactions. BloodTrack creates a record of the transfusion that may be printed for the patient’s record, stored, and uploaded to a remote database.
BloodTrack maintains an audit trail of each movement of the blood unit, from activation in the BloodTrack system through to final disposition, which can be remotely stored, displayed monitored, and printed.
Please refer to the manual for indications for use, contraindications, warnings, precautions and potential adverse events.