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

Catalog Number PMX110

Device Problem No Pressure (2994)

Patient Problem No Patient Involvement (2645)

Event Date 07/12/2018

Event Type  malfunction  

Manufacturer Narrative

Results: a pipe cleaner was inserted into the vacuum inlet and revealed blood inside the pump max.The device housing was opened by the penumbra investigator and dried blood was found on the inside of the device housing and vacuum pump.Conclusions: evaluation of the returned pump max revealed blood inside the pump max vacuum assembly.This is likely a result of incorrectly connecting the aspiration tubing directly to the vacuum inlet rather than the canister supplied by penumbra.This would allow blood to enter the vacuum assembly.If fluid is aspirated into the pump max, it will likely prevent the pump from functioning properly.Functional testing was performed and confirmed that the vacuum pump was unable to power on and unable to produce sufficient vacuum pressure.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.

Event Description

During preparation for a thrombectomy procedure, the hospital staff noticed that the motor of the penumbra system aspiration pump max 110 (pump max) did not produce any sound.The hospital staff checked the power cable connection and turned the pump max on and off multiple times; however, the pump max did not work at all.The issue with the pump max was found prior to use and therefore the pump max was not used in the procedure.The procedure was completed using another suction equipment.

• 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: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7791836
• MDR Text Key: 117432746
• Report Number: 3005168196-2018-01612
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K122756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PMX110
• Device Lot Number: F16091-06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Is the Reporter a Health Professional?: Yes
• 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: 07/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2015
• 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