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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 Failure to Power Up; Failure to Pump; Aspiration Issue
Event Date 12/02/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Results: the fuse box was not securely inserted into the inlet port. The fuse box would not securely latch in the inlet port. Upon first activating the pump, no components of the pump turned on. The fuse box was pushed into the inlet port by a penumbra investigator, and despite the fuse box not securely latching inside the inlet port, the pump was able to generate fully adjustable vacuum. Conclusions: evaluation of the returned pump revealed the fuse box was not securely inserted into the inlet port. The loosening of the fuse box may have occurred due to mishandling of the pump during preparation or use. When the fuse box was pushed into the inlet port by a penumbra investigator, the fuse box would not securely latch, but the pump was able to generate fully adjustable vacuum. 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 pump max did not produce aspiration and turned off. The physician was unable to turn it back on and the pump max was not used to complete the procedure. It is unknown how the procedure was completed; however, there was no report of an adverse effect on 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 Key6211227
Report Number3005168196-2016-01888
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation RADIOLOGIC TECHNOLOGIST
Type of Report Initial
Report Date 12/02/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/28/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberPMX110
Device LOT NumberF06844-01
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/19/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/15/2013
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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