Model Number PMX220 |
Device Problems
Misconnection (1399); Device Handling Problem (3265)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/23/2019 |
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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The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 220 (pump max).During the procedure, the aspiration tubing (tubing) was accidentally connected directly to the pump max rather than the indigo pump max canister (canister).Consequently, fluid was aspirated into the pump max and it started smoking and shut down.Therefore, the pump max was removed.The procedure was completed using manual aspiration.There was no report of an adverse effect to the patient.
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Manufacturer Narrative
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Results: a pipe cleaner was inserted into the pump max vacuum inlet and no presence of fluid was detected.The device housing was opened, and fluid was found within the vacuum tubing.Fluid residue was found within the device housing.Conclusions: evaluation of the returned pump max confirmed fluid within the device.If the tubing is connected directly to the vacuum inlet, fluid may aspirate into the pump max.If fluid is aspirated into the device, the pump max may not function properly.Penumbra pumps are 100% 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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Manufacturer Narrative
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Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #02 mfr report:3005168196-2019-01040.
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Search Alerts/Recalls
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