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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 Contamination During Use; Misconnection; Device Contamination with Body Fluid
Event Date 11/07/2018
Event Type  Malfunction  
Manufacturer Narrative

Results: dried blood was found on the pump housing. Blood was present inside the pump. Conclusions: evaluation of the returned pump max revealed blood within the vacuum assembly and on the pump housing. If the aspiration tubing is connected directly to the vacuum inlet rather than the pump canister, supplied by penumbra, blood will likely be aspirated directly into the vacuum assembly. Fluid being aspirated into the pump will likely cause the device to become non-functional. 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 staff accidentally connected the aspiration tubing (tubing) directly to the pump max rather than the canister. Consequently, blood was aspirated into the pump max and it stopped working; therefore, the pump max was disconnected. The procedure was completed using manual aspiration. 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 Key8144676
Report Number3005168196-2018-02393
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,11/09/2018
2 DeviceS WERE Involved in the Event: 1   2  
0 PatientS WERE Involved in the Event:
Date FDA Received12/07/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPMX110
Device LOT NumberF20722-17
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/15/2018
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 Received11/09/2018
Date Device Manufactured02/09/2016
Is this a Reprocessed and Reused Single-Use Device? No

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