It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the heart lung machine (hlm) displayed a 'you have exceeded the 2-year service life of your batteries' message earlier than expected.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
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The reported complaint was confirmed.Per log data analysis, the system is used on (b)(6) 2020 and there is no indication of a problem.On the next power up the date changed to (b)(6) 2046.This triggered the 'you have exceeded the 2-year service life of your batteries' message as reported.Most likely the actual date was (b)(6) 2020.The log confirms the complaint.The issue was caused by the central control monitor randomly changing the date.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
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