Catalog 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 06/08/2019 |
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 220 (pump max).During the procedure, the hospital staff accidentally connected the aspiration tubing (tubing) directly to the pump max rather than the canister.Consequently, blood was aspirated into the pump max; therefore, the pump max was disconnected.The procedure was completed using another pump max.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 vacuum inlet and blood was observed inside the pump assembly.Conclusions: evaluation of the returned pump max confirmed that blood was aspirated into the pump assembly.The complaint mentioned that the aspiration tubing was connected to the pump max vacuum inlet instead of the canister supplied by penumbra.If this occurs, fluid may enter the vacuum assembly and the device may not function properly.Penumbra pumps are functionally tested during incoming inspection and during quality inspection after manufacturing.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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Search Alerts/Recalls
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