The dual patient line involved in the incident has not been returned for investigation.The library/retain sample for this lot was reviewed and no manufacturing issues were noted.The manufacturing batch records for this lot were also reviewed and no anomalies were identified.All dual patient lines are 100% leak tested and 100% visually inspected prior to release from belmont medical technologies.A review of past complaints indicates that there have been no other complaints related to this lot number.When the rapid infuser detects a situation that is compromising effective infusion, the system stops pumping and heating, closes off the line to the patient, sounds an audible alarm, and displays an alarm message with instructions for corrective measure.It was reported that there was no harm to the patient.We will continue to monitor and trend similar reports of this nature and take further action if required.Should additional information become available, a supplemental report will be provided.
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Belmont's distributor received a complaint from the user facility involving three disposable products (3-spike disposable set, 3.0 liter reservoir, and dual patient line) and relayed the following report: "during open heart surgery, #102 over temperature error occurred after about 5 hours of using ri-2.The user has replaced the new disposable kit." this report is for the dual patient line; separate reports will be entered for the 3-spike disposable set and 3.0 liter reservoir.
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