Catalog Number PMX220 |
Device Problems
Failure to Power Up (1476); Device Operates Differently Than Expected (2913)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/13/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
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Event Description
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During preparation for a thrombectomy procedure, the hospital staff noticed that the penumbra system aspiration pump max 220v (pump max) failed to power on when the green "on/off" button was pushed and that it did not make the usual fan noise.Several attempts were made to get the pump max to work but were unsuccessful.Therefore, the procedure was completed using a syringe.
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Manufacturer Narrative
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Result: there was no visible damage to the exterior of the pump.The pump was plugged in and powered on and was found to generate vacuum.The pump was opened by the penumbra investigator and no damage or abnormalities were observed.Conclusion: evaluation of the returned device revealed that the pump was functional.The pump was plugged in and powered on and was found to generate vacuum.The pump was opened by the penumbra investigator and no damage or abnormalities were observed.If the pump is used to generate vacuum and then turned off, it may have to return to equilibrium with atmospheric pressure before it can generate vacuum again.Penumbra pumps are 100% 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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Manufacturer Narrative
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Further evaluation of the returned device was performed on 08/09/2016: results: the pump was opened by penumbra engineers and corrosion was observed on the piston crown in the outlet cylinder.Conclusions: the pump housing was removed, and the vacuum pump was opened by penumbra investigators.It was observed that the piston crown in the outlet cylinder was corroded.The observed corrosion likely caused the piston to seize inside the cylinder, causing the pump to fail to generate vacuum.It is likely that the seized piston became freed up during transit to penumbra.The root cause of the corrosion could not be determined.Based on the information above, the results codes and conclusions codes are being updated.
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Search Alerts/Recalls
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