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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 Failure to Power Up; Device Damaged Prior to Use ; Device Contamination with Body Fluid
Event Date 02/20/2018
Event Type  Malfunction  
Manufacturer Narrative

Results: a pipe cleaner was inserted through the vacuum inlet port and blood was observed inside the pump max. Conclusions: evaluation of the returned pump max revealed that the pump had blood inside. This type of damage typically occurs due to improper handling during use. If the aspiration tubing is connected directly to the vacuum inlet rather than the canister supplied by penumbra, blood will likely enter the pump assembly. Blood in the pump assembly may contribute to the reported issue. Penumbra pumps are 100% functionally tested during incoming inspection by quality. The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

 
Event Description

During preparation of a thrombectomy procedure, a penumbra system aspiration pump max 110v (pump max) would not turn on. It was discovered that blood was in the pump max. The procedure was completed using manual aspiration with a syringe.

 
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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 Key7334376
Report Number3005168196-2018-00550
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 02/20/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/13/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberPMX110
Device LOT NumberF26322-32
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/26/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/09/2017
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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