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.
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It was reported that biomed stated the arctic sun device was sent down for not rewarming a patient, while they were troubleshooting, noticed that during the functional check the device was heating and cooling fine, but the bypass flow rate was not reaching a minimum of 1.5 lpm like it stated in the service manual, coming back for service under the service warranty.Per sample evaluation results on (b)(6) 2024, it was reported that white powdery residue found around the o-ring sealing of the pressure transducer.
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