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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 Device Contamination with Body Fluid; Device Handling Problem; Noise, Audible
Event Date 03/14/2017
Event Type  Malfunction  
Manufacturer Narrative

This device is available for return. A follow up mdr will be submitted upon completion of the device investigation.

 
Event Description

The patient was undergoing a thrombectomy procedure in the anterior tibial artery using a penumbra system aspiration pump max 110v (pump max). During the procedure, the aspiration tubing was directly connected to the pump max and consequently, a small amount of blood entered inside the pump max. After that, the physician noticed that the pump max was making an unusual sound; therefore, the physician decided to stop using the pump max. The procedure was completed using another manufacturer¿s catheter to drip thrombolytics overnight. There was no report of an adverse effect to the patient.

 
Manufacturer Narrative

Results: a pipe cleaner was inserted into the pump max vacuum port, and blood was observed to be inside the pump. Conclusions: evaluation of the returned device confirmed that blood was inside the pump max. 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 pump max was not functionally tested during the functional analysis. 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.

 
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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 Key6483569
Report Number3005168196-2017-00576
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/01/2005,03/14/2017
2 DeviceS WERE Involved in the Event: 1   2  
0 PatientS WERE Involved in the Event:
Date FDA Received04/11/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberPMX110
Device LOT NumberF23878-01
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/15/2017
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 Manufactured09/08/2016
Is this a Reprocessed and Reused Single-Use Device? No

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