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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. PUMP MAX 110V JCX

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PENUMBRA, INC. PUMP MAX 110V JCX Back to Search Results
Catalog Number PMX110
Device Problems Device Emits Odor; Device Operational Issue; No Pressure
Event Date 02/19/2016
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 in the middle cerebral artery 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) in the patient before switching the pump max on. However, the physician confirmed that the pump max was not producing any vacuum and emitted a strange burning-like smell. The procedure was completed using the 5max ace and another manufacturer's device. There was no report of an adverse effect to the patient.

 
Manufacturer Narrative

The customer kept the device. 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.

 
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Brand NamePUMP MAX 110V
Type of DeviceJCX
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer (Section G)
PENUMBRA, INC.
Manufacturer Contact
kathleen kidd
one penumbra place
alameda , CA 94502
5107483200
MDR Report Key5535631
Report Number3005168196-2016-00375
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/01/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/30/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberPMX110
Device LOT NumberF14881-20
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 Received03/01/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/03/2015
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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