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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 Failure to Pump; Device Operates Differently Than Expected; No Pressure
Event Date 05/31/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). 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 220v (pump max). During the procedure, the pump max was turned on; however, there was no vacuum being produced. The hospital staff disconnected the aspiration tubing and plugged the canister with a finger in order to create suction; however, no vacuum was being produced. It was noticed that the gauge was not moving at all and the pump max was producing a duller than usual sound when turned on. The pump max was then disconnected from all catheters and was left in the room still powered on. The procedure was successfully completed using a stent retriever and there was no report of an adverse effect to the patient. Approximately 10 minutes after the pump max had been left in the room still powered on, the hospital staff noticed the pump max started to emit a burning smell. A penumbra staff tested the pump max the next day and it seemed to work as intended with no malfunction.

 
Manufacturer Narrative

Result: the pump was plugged in and powered on. Upon power-up the pump was able to reach maximum vacuum. There was no visible damage to the exterior of the pump. The pump was opened by penumbra engineers and corrosion was observed on the piston crown in the outlet cylinder. Conclusion: evaluation of the returned pump revealed that the pump was able to power on and achieve full vacuum. The pump housing was removed, and the vacuum pump was opened by penumbra investigators. It was observed that the piston crown in the outlet cylinder was corroded. The observed corrosion likely caused the piston to seize inside the cylinder, causing the pump to fail to generate vacuum. It is likely that the seized piston became freed up during transit to penumbra. 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 220V
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 Key5763456
Report Number3005168196-2016-00914
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/01/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/30/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberPMX220
Device LOT NumberF21233-01
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/12/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/14/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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