Catalog Number PMX220 |
Device Problems
Device Operational Issue (2914); No Pressure (2994)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/20/2015 |
Event Type
malfunction
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Manufacturer Narrative
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This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
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Event Description
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The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 220v (pump max).During the procedure, the pump max did not produce any vacuum when the "on/off" switch was pushed.The procedure was completed with manual aspiration.
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Manufacturer Narrative
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On (b)(6) 2016, confirmation was received that there was no adverse effect to the patient.Result: there was no visible damage to the exterior of the penumbra system aspiration pump max (pump).The pump was powered on multiple times and functioned without an issue.The pump generated vacuum each time it was powered on.Conclusion: evaluation of the retuned device revealed that the pump was functional.The pump was powered on multiple times and the pump generated vacuum each time it was powered on.Therefore, the root cause of the complaint cannot be determined.The pumps are 100% functionally tested during incoming inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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Event Description
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There was no adverse effect to the patient.
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Manufacturer Narrative
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Please note that this report was initially submitted on 06/01/2017; however, the submission failed because it was marked as follow-up #1 instead of follow-up #2.Additional investigation was performed on the returned device with results and conclusions as follows: results: the penumbra system aspiration pump max 220v (pump max) was opened by a penumbra investigator and corrosion was observed on the outlet piston crown.Conclusions: the observed corrosion likely prevented the pump from powering on.The seized piston likely became jarred loose in transit of the pump being returned to penumbra.
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Search Alerts/Recalls
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