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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 Misconnection; Device Contamination with Body Fluid; Device Handling Problem
Event Date 07/29/2018
Event Type  Malfunction  
Manufacturer Narrative

Results: blood was present on the device housing of the pump max and inside the device housing. Conclusions: evaluation of the returned pump max confirmed blood inside the vacuum pump assembly. This is likely a result of the reported incorrect connection of the aspiration tubing directly to the pump max vacuum inlet instead of the canister supplied by penumbra. This will allow blood to enter the vacuum pump assembly. If fluid enters the vacuum pump assembly, 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 staff inadvertently disconnected the aspiration tubing (tubing) to the pump max and, consequently, blood was aspirated directly into the pump max during the procedure. The procedure was able to be completed with one pass, despite the tubing being disconnected. There was no report of an adverse effect to the patient.

 
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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 Key7819716
Report Number3005168196-2018-01682
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,07/29/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/27/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPMX110
Device LOT NumberF19969-25
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/16/2018
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 Received07/29/2018
Is this a Reprocessed and Reused Single-Use Device? No

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