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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 Device Contamination with Body Fluid; Device Handling Problem
Event Date 03/11/2018
Event Type  Malfunction  
Manufacturer Narrative

Results: a pipe cleaner was inserted into the vacuum inlet 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. The blood inside the pump max likely contributed to the pump not producing aspiration. The tubing referred to in the complaint was not returned for evaluation. 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

The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 110v (pump max). During the procedure, the hospital staff inadvertently connected the tubing directly in to the body of the pump max, and consequently blood was aspirated into the pump max. The procedure was able to be completed using the same pump max. 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 Key7409103
Report Number3005168196-2018-00719
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 03/11/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/09/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberPMX110
Device LOT NumberF07421-37
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/14/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/04/2014
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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