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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 Operational Issue; No Pressure
Event Date 02/22/2016
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 physician advanced a penumbra system 5max ace reperfusion catheter (5max ace) into the patient and switched the pump max on in order to start aspirating thrombus. However, the physician could not confirm that any vacuum was being produced and turned off the pump max. After verifying that the tubing was properly connected, the physician restored the regulator knob and turned the pump max back on but no vacuum was produced. Therefore, the procedure was completed using a stent. There was no report of an adverse effect to the patient.

 
Manufacturer Narrative

Results: there was no visible damage to the pump. The pump was plugged in and powered on. The pump only made a humming sound like a fan was running, and no vacuum was produced. The pump was opened by penumbra engineers and corrosion was observed on the piston crown in the outlet cylinder. Conclusions: evaluation of the returned device revealed the pump was nonfunctional. The pump was opened by penumbra engineers and corrosion was observed on the piston crown in the outlet cylinder. The observed corrosion likely caused the piston to seize inside the cylinder. The root cause of this corrosion could not be determined. Penumbra pumps are 100% 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 110V
Type of DeviceJCX
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer (Section G)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
kathleen kidd
one penumbra place
alameda , CA 94502
5107483200
MDR Report Key5520759
Report Number3005168196-2016-00347
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/23/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/23/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberPMX110
Device LOT NumberF14222-09
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/04/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/11/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/13/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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