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

Catalog Number PMX110

Device Problems Failure to Pump (1502); No Pressure (2994)

Patient Problem No Patient Involvement (2645)

Event Date 04/18/2016

Event Type  malfunction  

Manufacturer Narrative

Results: the penumbra system aspiration pump max 110v (pump max) was opened by a penumbra investigator and corrosion was present on the piston crown of the outlet cylinder.Conclusions: evaluation of the returned device revealed that the pump was functional.The pump was plugged in and powered on and generated fully adjustable vacuum.The pump was opened by the penumbra investigator.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, preventing the pump from functioning.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.

Event Description

During preparation for a thrombectomy procedure, while testing a penumbra system aspiration pump max 110v (pump max), the technologist noticed that when the pump max was switched on, the green on/off button illuminated; however, the pump did not run and the motor did not come on.The technologist then hit the back of the pump max a couple of times and it started up and ran fine.The procedure was completed using the same pump max.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V
• Type of Device: JCX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5664837
• MDR Text Key: 45473363
• Report Number: 3005168196-2016-00679
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Catalogue Number: PMX110
• Device Lot Number: F07464-30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1