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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; Device Damaged Prior to Use ; No Pressure
Event Date 09/29/2016
Event Type  Malfunction  
Manufacturer Narrative

Results: blood on a pipe cleaner was observed around and inside the penumbra system aspiration pump max 110v (pump max) inlet. Conclusions: evaluation of the pump revealed blood in and around the pump vacuum inlet. 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. The observed blood likely contributed to the pump max not producing vacuum during the procedure. Penumbra pumps are visually and functionally inspected 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, the hospital technologist noticed that a penumbra system aspiration pump max 110v (pump max) did not produce vacuum when turned on. It was reported that the pump max green light button illuminated and that the fan like noise was produced; however, the typical "pumping" noise was not produced. The issue with the pump max was noticed prior to use and therefore this pump max was not used in the procedure. The procedure was successfully completed using manual aspiration.

 
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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
veronica farris
one penumbra place
alameda , CA 94502
5107483200
MDR Report Key6064615
Report Number3005168196-2016-01528
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 09/30/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/28/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator RADIOLOGIC TECHNOLOGIST
Device Catalogue NumberPMX110
Device LOT NumberF19378-09
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/11/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/13/2016
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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