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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 Failure to Power Up (1476); Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 05/06/2016
Event Type  Malfunction  
Manufacturer Narrative

This device is available for return. A follow up mdr will be submitted upon completion of the device investigation.

 
Event Description

During preparation for a thrombectomy procedure, the physician noticed that the penumbra system aspiration pump max 220v (pump max) did not power on when the green "on/off" switch was pushed and that the pump max did not make any noise. The physician made several attempts to turn on the pump max but was unsuccessful. Therefore, the pump max was not used for the procedure and did not come into contact with the patient. The procedure was completed using a syringe.

 
Manufacturer Narrative

Result: there was no visible damage to the exterior of the pump. The pump was plugged in and powered on and was found to generate vacuum. The pump was opened by penumbra engineers and corrosion was observed on the piston crown in the outlet cylinder. Conclusion: evaluation of the returned device revealed that the pump was functional. The pump was plugged in and powered on and was found to generate vacuum. The pump housing was removed, and the vacuum pump was opened by penumbra investigators. 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, causing the pump to fail to generate vacuum. It is likely that the seized piston became freed up during transit to penumbra. 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.

 
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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 Key5704684
MDR Text Key46763004
Report Number3005168196-2016-00751
Device Sequence Number1
Product Code JCX
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK122756
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/09/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/07/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberPMX220
Device LOT NumberF16550-09
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/08/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/13/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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