Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #3005168196-2019-01657 mfr report: 1.Section h.Box 5.Labeled for single use? 2.Section h.Box 8.Usage of device.Results: a pipe cleaner was inserted into the pump max vacuum inlet and blood was observed inside the vacuum assembly (figure 2).Conclusions: evaluation of the returned pump max revealed that blood was aspirated inside its vacuum assembly.If the aspiration tubing is connected directly to the vacuum inlet instead of the canister, supplied by penumbra, blood will likely be aspirated into the vacuum assembly.If fluid is aspirated into the vacuum assembly, the pump may not function properly.Penumbra pumps are visually inspected and functionally tested during incoming quality inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text : placeholder.
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