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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 Misconnection; Device Contamination with Body Fluid; Device Handling Problem
Event Date 05/04/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Results: a pipe cleaner was inserted into the pump max vacuum inlet and blood was observed inside the pump. Conclusions: evaluation of the returned pump max revealed blood inside the vacuum assembly. This is likely a result of incorrectly connecting the aspiration tubing directly to the pump max vacuum inlet bypassing the canister supplied by penumbra. If fluid is aspirated into the pump max, it may prevent the pump from functioning properly. Penumbra pumps are visually inspected and 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 110 (pump max). During the procedure, the hospital technician did not use a pump max canister and accidentally connected the penumbra system max aspiration tubing (tubing) directly to the pump max and, consequently, blood was aspirated into the body of the pump max. It was noted that the pump max was able to turn on, but the aspiration levels were low after blood had been aspirated when the tubing was incorrectly connected. The procedure was completed using the pump max, additionally; 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 Key7561907
Report Number3005168196-2018-01083
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 05/04/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/01/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator RADIOLOGIC TECHNOLOGIST
Device Catalogue NumberPMX110
Device LOT NumberF24064-17
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/17/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/19/2016
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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