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

Catalog Number PMX220

Device Problems Device Emits Odor (1425); Power Conditioning Problem (1474)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2017

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 220 (pump max).During the procedure, the pump max was going on and off, and smelled like the motor was burned.Therefore, the pump max was disconnected and the procedure was completed using another pump max.There was no report of an adverse effect to the patient.

Manufacturer Narrative

There was no visible damage to the pump exterior.Evaluation of the returned pump max revealed it was able to power on and achieve sufficient vacuum levels.The device did not cut out or emit a burning smell when functionally tested.Penumbra pumps are 100% functionally tested and visually inspected during incoming inspection by quality.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7041294
• MDR Text Key: 93081623
• Report Number: 3005168196-2017-02018
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00814548012698
• UDI-Public: 00814548012698
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K122756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/23/2017

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
• Device Operator: Physician
• Device Catalogue Number: PMX220
• Device Lot Number: F25163-22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2017
• Initial Date FDA Received: 11/17/2017
• Supplement Dates Manufacturer Received: 01/11/2018
• Supplement Dates FDA Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2012
• 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
• Patient Age: 61 YR