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

Catalog Number PMX110

Device Problems Device Stops Intermittently (1599); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2016

Event Type  malfunction  

Manufacturer Narrative

Results: the handle on top of the penumbra system aspiration pump max 110v (pump max) was loose on the left side when viewed from the front.Conclusions: evaluation of the returned device revealed that upon powering on, the pump could reach full vacuum pressure within specification, and was able to run without issue for 30 minutes.If the pump is turned off, the pressure inside the pump should be allowed to equalize before turning it back on.The root cause of the pump shutting off could not be determined.The pump functioned as intended upon evaluation.Further evaluation revealed that the handle on top of the pump was loose on one side.This failure was unassociated with the reported complaint.These devices are 100% functionally tested during 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, while aspirating clot, the pump max suddenly stopped on its own.After repeated attempts to turn on the pump max, it finally powered on within 20 seconds.The procedure was completed using this same pump max.There was no report of an adverse effect to the patient.

Manufacturer Narrative

The pump was opened by a penumbra investigator, and it was observed that one of the screws that connects the pump handle to the pump housing was loose.The loose screw likely caused the pump handle to be loose.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V
• Type of Device: JCX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5487439
• MDR Text Key: 39935932
• Report Number: 3005168196-2016-00298
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: PMX110
• Device Lot Number: F07835-38
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1