Catalog Number PMX110 |
Device Problems
Misconnection (1399); Use of Device Problem (1670); Device Contamination with Body Fluid (2317)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/23/2019 |
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 in the proximal left anterior descending artery (lad) using a penumbra system aspiration pump max 110 (pump max).During the procedure, the physician noticed that blood was entering the pump max as it was aspirating.The physician then found that the indigo system catrx aspiration catheter (catrx) was connected incorrectly to the pump max, allowing for blood to enter.The catrx and connection tubes were then re-adjusted and connected correctly to the pump max, and the procedure resumed.The procedure was completed using the same catrx and the same pump max.There was no report of an adverse effect to the patient.
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Manufacturer Narrative
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Results: dried blood was found on the pump housing and inside the vacuum inlet.Conclusions: evaluation of the returned pump max confirmed blood was aspirated inside the vacuum pump.The reported complaint indicated that the aspiration tubing was directly connected to the pump vacuum inlet instead of the canister supplied by penumbra and blood was subsequently aspirated into the pump.If the fluid enters the vacuum pump assembly, the pump 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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Search Alerts/Recalls
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