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U.S. Department of Health and Human Services

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

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PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 JCX Back to Search Results
Catalog Number PMX110
Device Problems Electrical /Electronic Property Problem; Failure to Power Up
Event Date 10/09/2017
Event Type  Malfunction  
Manufacturer Narrative

Results: the label on the back of the penumbra system aspiration pump max 110 (pump max) was evaluated. The fuses were blown inside the pump max. Conclusion: evaluation of the returned pump max confirmed that the fuses were blown. The pump max was plugged in an attempt to power it on; however, when the green light was depressed no power was observed. The fuses were removed from the back of the pump max by the penumbra investigator and it was determined that they were blown. The fuses were changed and the pump max was powered on and ran for 30 minutes without an issue. The root cause of the fuses being blown could not be determined. Penumbra pumps are 100% functionally tested during incoming inspection by quality. The manufacturing records for this serial number were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

 
Event Description

The patient was undergoing a thrombectomy procedure to treat an arteriovenous fistula thrombosis using a penumbra system aspiration pump max 110 (pump max). During the procedure, the pump max had a blown fuse and would not restart. Therefore, the pump max was disconnected and the procedure was completed using a new pump max. There was no report of an adverse effect to the patient.

 
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Brand NamePENUMBRA SYSTEM ASPIRATION PUMP MAX 110
Type of DeviceJCX
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda , CA 94502
5107483200
MDR Report Key6992010
Report Number3005168196-2017-01929
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/01/2005,10/09/2017
2 DeviceS WERE Involved in the Event: 1   2  
0 PatientS WERE Involved in the Event:
Date FDA Received10/31/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberPMX110
Device LOT NumberF24064-34
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/12/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report TO Manufacturer01/10/2005
Date Manufacturer Received01/14/2005
Date Device Manufactured09/19/2016
Is this a Reprocessed and Reused Single-Use Device? No

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