(b)(4).Results: the fuse box was not securely inserted into the inlet port.The fuse box would not securely latch in the inlet port.Upon first activating the pump, no components of the pump turned on.The fuse box was pushed into the inlet port by a penumbra investigator, and despite the fuse box not securely latching inside the inlet port, the pump was able to generate fully adjustable vacuum.Conclusions: evaluation of the returned pump revealed the fuse box was not securely inserted into the inlet port.The loosening of the fuse box may have occurred due to mishandling of the pump during preparation or use.When the fuse box was pushed into the inlet port by a penumbra investigator, the fuse box would not securely latch, but the pump was able to generate fully adjustable vacuum.Penumbra pumps are visually and functionally inspected during incoming quality inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 110v (pump max).During the procedure, the pump max did not produce aspiration and turned off.The physician was unable to turn it back on and the pump max was not used to complete the procedure.It is unknown how the procedure was completed; however, there was no report of an adverse effect on the patient.
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