The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
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It was reported that biomed has a arctic sun device that was sent down because it was unable to maintain patient temperature, several 113 (reduced water temperature control) alerts in the event log and confirmed an issue with cooling.Device would not cool during the calibration, it failed for an error 80 (water check time out - unable to reach calibration temperature)expected 6 actual 28.48.Chiller temperature (t4) was 29 degrees and had water in chiller tank.
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