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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V JCX

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PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V JCX Back to Search Results
Catalog Number PMX220
Device Problems Aspiration Issue; Device Operates Differently Than Expected; No Pressure
Event Date 06/06/2016
Event Type  Malfunction  
Manufacturer Narrative

Results: there is no visible damage to the exterior of the penumbra system pump max 220v (pump max). Conclusions: evaluation of the returned device revealed no issue with the pump max. The pump max was plugged in and powered on and full vacuum pressure was present. Therefore, the pump max was functional. The root cause of this complaint could not be determined. Pumps are 100% functionally tested during in-process inspection. The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

 
Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system pump max 220v (pump max). During the procedure, the pump max was successfully used on the first attempt to aspirate the thrombus and was then switched off. Upon switching the pump max back on for the second pass, the pump max did not produce any vacuum and was unable to aspirate the thrombus. Therefore, the second pass was performed using a syringe. A third pass was still needed to remove the thrombus so the pump max was switched on and started to produce vacuum again. Therefore, the pump max was successfully used to complete the procedure. There was no report of an adverse effect to the patient.

 
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Brand NamePENUMBRA SYSTEM ASPIRATION PUMP MAX 220V
Type of DeviceJCX
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
kathleen kidd
one penumbra place
alameda , CA 94502
5107483200
MDR Report Key5773679
Report Number3005168196-2016-00937
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 06/07/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/06/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberPMX220
Device LOT NumberF09147-52
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/20/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/03/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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