It was reported that the biomed had replaced valves in the arctic sun device and was still getting a valve pressure error.Per sample evaluation results received on 03feb2023, the ac cca card showed signs of electrical overstress.The tank tubing was expanded and replaced due to normal wear as preventive maintenance.Replaced flow meter due to extensive hours as preventive maintenance.Per sample evaluation results received on 08feb2023, it was reported that the double bend tube and 1/2 l shaped tube were expanded.
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The reported issue was confirmed.The device was evaluated and the reported issue was confirmed as it noted that the ac cca card showed signs of electrical overstress.Replaced cca ca card.Performed 2k pm service on the unit.Serviced the mixing, and circulation pumps.Replaced the heater # 1625, with new heater # 2151, drain valves.Performed a functional check and pre-cal the device after the repairs.Placed on acats (automated calibration and test system).Passed acats and document testing.Performed an electrical safety test.Passed electrical testing and documented testing.Completed the final inspection.The unit is functioning properly.The arctic sun 5000 passed all performance testing, calibration, and electrical safety tests.The unit is ready for use.The overheating of the wires was assessed by the investigation tasks and used to complete the root cause evaluation using the fishbone methodology (refer to ac cca power inlet module powerpoint for fishbone diagram).It was concluded that the following was the root cause: supplier ¿ root cause: inadequate verification and validation activities of the crimping process.Single pull test did not provide stability of process.Evidence was not provided when requested for maintenance of records or crimp tools.No crimp cross-sections provided.The device did not meet specifications, and was influenced by the reported failure.The device was not in use on a patient.The dhr review is not required and the labeling review is not required because labeling could not have prevented this issue.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 actual/suspected device was inspected.
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It was reported that the biomed had replaced valves in the arctic sun device and was still getting a valve pressure error.Per sample evaluation results received on 03feb2023, the ac cca card showed signs of electrical overstress.The tank tubing was expanded and replaced due to normal wear as preventive maintenance.Replaced flow meter due to extensive hours as preventive maintenance.Per sample evaluation results received on 08feb2023, it was reported that the double bend tube and 1/2 l shaped tube were expanded.
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