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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V JCX

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PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V JCX Back to Search Results
Catalog Number PMX110
Device Problems Failure to Pump; No Pressure
Event Date 04/18/2016
Event Type  Malfunction  
Manufacturer Narrative

Results: the penumbra system aspiration pump max 110v (pump max) was opened by a penumbra investigator and corrosion was present on the piston crown of the outlet cylinder. Conclusions: evaluation of the returned device revealed that the pump was functional. The pump was plugged in and powered on and generated fully adjustable vacuum. The pump was opened by the penumbra investigator. It was observed that the piston crown in the outlet cylinder was corroded. The observed corrosion likely caused the piston to seize inside the cylinder, preventing the pump from functioning. The root cause of this corrosion could not be determined. Penumbra pumps are 100% 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.

 
Event Description

During preparation for a thrombectomy procedure, while testing a penumbra system aspiration pump max 110v (pump max), the technologist noticed that when the pump max was switched on, the green on/off button illuminated; however, the pump did not run and the motor did not come on. The technologist then hit the back of the pump max a couple of times and it started up and ran fine. The procedure was completed using the same pump max.

 
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Brand NamePENUMBRA SYSTEM ASPIRATION PUMP MAX 110V
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 Key5664837
Report Number3005168196-2016-00679
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 04/18/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/18/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator RADIOLOGIC TECHNOLOGIST
Device Catalogue NumberPMX110
Device LOT NumberF07464-30
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/06/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/21/2014
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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