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

Catalog Number PMX110

Device Problems Device Contamination with Body Fluid (2317); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2016

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 using a penumbra system aspiration pump max 110v (pump max). During the procedure, the hospital technologist inadvertently connected the aspiration tubing directly to the pump max. Consequently, blood and fluid entered the pump when aspiration was initiated. Although, blood and fluid entered the pump max, the physician was able to complete the procedure using the same pump max. It was reported that the pump max started emitting smoke when it was turned on. There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the device was initially available for return; however, on 24-march-2017; additional information obtained confirmed that the hospital discarded of the device; therefore, no device evaluation could be performed. The product was not returned for evaluation. Without the return of the device, the root cause of the problem cannot be determined. The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns. The hospital disposed of the device.

• 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: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 6017039
• MDR Text Key: 56965824
• Report Number: 3005168196-2016-01447
• Device Sequence Number: 1
• Product Code: JCX
• 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

• Type of Report: Initial,Followup
• Report Date: 09/12/2016

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 10/11/2016
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: PMX110
• Device LOT Number: F12747-14
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/24/2017
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 10/04/2014
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse