During preparation for a medical procedure, the hospital staff noticed that the penumbra system aspiration pump max 110 (pump max) would turn on; however, it did not produce aspiration.The issue with the pump max was found prior to use and, therefore, was not used in the procedure.The procedure was completed using manual aspiration with a syringe.
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Please note that the following section was inadvertently missed on the initial mfr report and is being included on this follow-up #01 mfr report: 3005168196-2018-02492.Serial#.Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report: 3005168196-2018-02492.Device evaluated by manufacturer? reason for non-evaluation.Results code 1.Conclusion code 1.Results: dried blood was found inside the vacuum inlet nozzle.The blood found inside the vacuum inlet nozzle; therefore, functional testing could not be performed.Conclusions: evaluation of the returned pump max revealed dried blood inside the pump inlet nozzle.If the aspiration tubing is connected directly to the vacuum inlet nozzle instead of the canister supplied by penumbra, blood will likely be aspirated into the vacuum pump assembly.If fluid is aspirated into the vacuum pump assembly, the pump max 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.
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