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

Catalog Number PMX220

Device Problems Device Emits Odor (1425); Device Damaged Prior to Use (2284); No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2016

Event Type  Malfunction  

Manufacturer Narrative

Result: the pump was powered on and functioned without an issue. There was no visible damage to the pump. Conclusion: evaluation of the returned device revealed that the pump was functional. The root cause of the pump not producing vacuum could not be determined. The pump was functionally tested and functioned without an issue. Pumps are 100% functionally tested during in-process inspection. The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 220v (pump max). During preparation for the procedure, the hospital staff noticed that when the pump max was switched on, it did not produce vacuum and also emitted a smell. The defective pump max was found prior to use and was not used for the procedure; instead, a syringe was used for the procedure. There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX
• Type of Device: JCX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483262
• MDR Report Key: 5542606
• MDR Text Key: 41697401
• Report Number: 3005168196-2016-00389
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (Y/N): N
• PMA/PMN Number: K122756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/02/2016

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 04/01/2016
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: PMX220
• Device LOT Number: F15888-24
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 03/29/2016
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/02/2016
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse