MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 220; JCX

Catalog Number PMX220

Device Problems Smoking (1585); Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2019

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the common carotid artery (cca)/right internal carotid artery (ica) using a penumbra system aspiration pump max 220 (pump max).During the procedure, the pump max started emitting smoke and stopped working.The physician was unable to turn the pump max back on and there was no aspiration.Therefore, the pump max was disconnected and the procedure was completed using a manual aspiration with a syringe.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the fuse port on the back of the pump was elevated.The fuse port was removed, and corrosion was found on the fuses.The pump max housing was opened, and blood was observed within the pump housing.Liquid was within the tubing and the piston.During functional testing, the pump max was powered on and the fan could be heard but no aspiration was observed.Conclusions: evaluation of the returned pump max revealed liquid within the tubing and pistons.This typically occurs if the tubing is connected directly to the pump instead of the canister, supplied by penumbra.If liquid is aspirated into the pump, the pump may not function properly.Further evaluation revealed corrosion within the pump housing and on the fuses on the back of the pump housing.These damages were likely a result of liquid being aspirated into the pump.Penumbra pumps are 100% visually inspected and 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.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 220
• Type of Device: JCX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9221921
• MDR Text Key: 163288306
• Report Number: 3005168196-2019-01971
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00814548012698
• UDI-Public: 00814548012698
• Combination Product (y/n): Y
• PMA/PMN Number: K160449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PMX220
• Device Lot Number: F17185-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• 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: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1