Based upon the clinical information available it is not possible to determine whether the patient's critical condition was due in part or in entirety as a result of the leaking disposable bowl.The bowl was returned for evaluation, a visual inspection confirmed the presence of cracks along the base of the bowl.The base diameter of the bowl was measured and found to meet dimensional specifications.The bowls were installed into a centrifuge chuck without problem.Submersion leak testing was performed, however a leak was not confirmed.A root cause of the bowl failure has not been established at this time, it is not possible to determine at which point during the product lifecycle the cracks developed along the bowl weld, it is possible that the bowls were damaged at some point after being released from manufacturing prior to use, either during product handling while shipping or during product handling during installation and procedure setup.Haemonetics attempted to reproduce the failure mode for cracks forming along the base weld of the bowl as well as for a leak at the base weld, it was not possible to reproduce the damages observed in the returned sample through the manufacturing process.The manufacturing process employs a 100% dynamic leak test for these products, the gross leaks found on the other returned products (reported under 1219343-2017-00016) would have been detected during the dynamic leak test.The damages which resulted with leaking products were not caused by any observable error or deviation in the manufacturing process.
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