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

Catalog Number PMX110

Device Problems Electrical /Electronic Property Problem (1198); Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the label on the back of the penumbra system aspiration pump max 110 (pump max) was evaluated.The fuses were blown inside the pump max.Conclusion: evaluation of the returned pump max confirmed that the fuses were blown.The pump max was plugged in an attempt to power it on; however, when the green light was depressed no power was observed.The fuses were removed from the back of the pump max by the penumbra investigator and it was determined that they were blown.The fuses were changed and the pump max was powered on and ran for 30 minutes without an issue.The root cause of the fuses being blown could not be determined.Penumbra pumps are 100% functionally tested during incoming inspection by quality.The manufacturing records for this serial number were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a thrombectomy procedure to treat an arteriovenous fistula thrombosis using a penumbra system aspiration pump max 110 (pump max).During the procedure, the pump max had a blown fuse and would not restart.Therefore, the pump max was disconnected and the procedure was completed using a new pump max.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report.Section d.Box 4.Lot #, section d.Box 4.Unique identifier and section h.Box 4.Device manufacture date.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110
• Type of Device: JCX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6992010
• MDR Text Key: 91514685
• Report Number: 3005168196-2017-01929
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): Y
• PMA/PMN Number: K122756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: PMX110
• Device Lot Number: F24064-34
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR