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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
Event Date 09/10/2016
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 using a penumbra system aspiration pump max 110v (pump max). During the procedure, the hospital technologist inadvertently connected the aspiration tubing directly to the pump max. Consequently, blood and fluid entered the pump when aspiration was initiated. Although, blood and fluid entered the pump max, the physician was able to complete the procedure using the same pump max. It was reported that the pump max started emitting smoke when it was turned on. There was no report of an adverse effect to the patient.

 
Manufacturer Narrative

Please note that the device was initially available for return; however, on 24-march-2017; additional information obtained confirmed that the hospital discarded of the device; therefore, no device evaluation could be performed. The product was not returned for evaluation. Without the return of the device, the root cause of the problem cannot be determined. The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns. The hospital disposed of the device.

 
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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
kathleen kidd
one penumbra place
alameda , CA 94502
5107483200
MDR Report Key6017039
Report Number3005168196-2016-01447
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/12/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/11/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberPMX110
Device LOT NumberF12747-14
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/24/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/04/2014
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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