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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 Problem No Pressure
Event Date 03/17/2016
Event Type  Malfunction  
Manufacturer Narrative

Results: the inlet port for the power cord was damaged. The penumbra system aspiration pump max 220v (pump max) was opened by a penumbra investigator and corrosion was observed on the piston crown in 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 vacuum. The pump was opened by the penumbra investigator and corrosion was observed on the piston crown of the outlet cylinder. The observed corrosion may have caused the piston to seize inside the cylinder. It is likely that the seized piston became freed-up during transit, allowing the pump to function during penumbra evaluation. Further evaluation revealed the inlet port of the power cord was damaged. The root cause of this complaint cannot 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

The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 220v (pump max). During the procedure, the pump max was switched on, however, no vacuum was produced. The procedure was completed by manual aspiration using a syringe. 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 Key5574940
Report Number3005168196-2016-00488
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/17/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/13/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberPMX220
Device LOT NumberF19958-23
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/07/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/30/2014
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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