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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V JCX

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PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V JCX Back to Search Results
Catalog Number PMX220
Device Problems Device Emits Odor; No Pressure
Event Date 11/04/2016
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 treating an occluded stent graft popliteal using a penumbra system aspiration pump max 220v (pump max). During the procedure, the pump max was switched on; however, no vacuum was produced. It was reported that the pump max emitted a bad smell. Therefore, the procedure was completed by manual aspiration using other aspiration catheters. There was no report of an adverse effect to the patient.

 
Manufacturer Narrative

Results: there was no visible damage to the exterior of the pump. Conclusions: evaluation of the returned pump confirmed that when the pump was powered on, the pump would not produce any vacuum. The pump was returned to the supplier for further evaluation. The pump was opened by the supplier and corrosion was observed on the outlet cylinder piston crown. The corrosion likely caused the piston to seize, and prevented the pump from generating vacuum pressure. Penumbra pumps are visually 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.

 
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Brand NamePENUMBRA SYSTEM ASPIRATION PUMP MAX 220V
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 Key6143013
Report Number3005168196-2016-01764
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/04/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/02/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPMX220
Device LOT NumberF21927-26
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/19/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/09/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/03/2016
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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