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 the arctic sun device sometimes did not absorb correctly.Per sample evaluation results on 28mar2024, it was reported that the quick check performed on the arctic sun device and found that the flow rate and pressure fluctuate sporadically.Manifold assembly and input/output circuit card defective.The hose from the circulation pump was too large, so that the plug on the hose was hanging loose.The diameter of the hose was approx.3 mm larger than the hose from a new circulation pump.
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