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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 Problem Failure to Power Up
Event Date 02/13/2017
Event Type  Malfunction  
Manufacturer Narrative

Results: there was no visible damage to the exterior of the penumbra aspiration pump max 110 (pump max). Conclusions: evaluation of the retuned device revealed that the pump max was functional. The pump max was powered on multiple times and the pump generated full vacuum each time it was powered on. The pump max was run for 30 minutes without an issue. Therefore, the root cause of the complaint cannot be determined. 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.

 
Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 110v (pump max). During the procedure, the physician successfully used a pump max with an indigo system aspiration catheter 8 (cat8) for about 10 to 15 minutes. After removing the cat8 for flush, the pump max powered off by itself. All the electrical cords were checked and the pump max was turned on again; however, the pump max powered off again after working for about 10 seconds. Therefore the procedure was successfully completed using another pump max and the same cat8. There was no report of an adverse effect to the patient.

 
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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
veronica farris
one penumbra place
alameda , CA 94502
5107483200
MDR Report Key6406150
Report Number3005168196-2017-00363
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 02/13/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/15/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberPMX110
Device LOT NumberF08059-39
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/06/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/13/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/25/2013
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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