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

Catalog Number	PMX220
Medical Device Problem Codes	Smoking (1585); Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem 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.
Additional 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
• Common Device Name: JCX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9221921
• Report Number: 3005168196-2019-01971
• Device Sequence Number: 2734311
• Product Code: JCX
• UDI-Device Identifier: 00814548012698
• UDI-Public: 00814548012698
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2019
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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 to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005