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

Catalog Number PMX110

Device Problems Failure to Pump (1502); Device Damaged Prior to Use (2284); No Pressure (2994)

Patient Problem No Patient Involvement (2645)

Event Date 09/29/2016

Event Type  malfunction  

Manufacturer Narrative

Results: blood on a pipe cleaner was observed around and inside the penumbra system aspiration pump max 110v (pump max) inlet.Conclusions: evaluation of the pump revealed blood in and around the pump vacuum inlet.If the aspiration tubing is connected directly to the vacuum inlet rather than the canister supplied by penumbra, blood will likely enter the pump assembly.The observed blood likely contributed to the pump max not producing vacuum during the procedure.Penumbra pumps are visually and functionally inspected 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 technologist noticed that a penumbra system aspiration pump max 110v (pump max) did not produce vacuum when turned on.It was reported that the pump max green light button illuminated and that the fan like noise was produced; however, the typical "pumping" noise was not produced.The issue with the pump max was noticed prior to use and therefore this pump max was not used in the procedure.The procedure was successfully completed using manual aspiration.

• 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: 6064615
• MDR Text Key: 58771883
• Report Number: 3005168196-2016-01528
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Catalogue Number: PMX110
• Device Lot Number: F19378-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2016
• 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