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

Catalog Number PMX110

Device Problems Device Emits Odor (1425); Smoking (1585); Device Operational Issue (2914); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2016

Event Type  malfunction  

Manufacturer Narrative

Results: there was no visible damage to the exterior of the penumbra system aspiration pump max 110v (pump max).Conclusions: evaluation of the retuned device revealed that the pump was functional.The pump was powered on multiple times and the pump generated vacuum each time it was powered on.Furthermore, no unusual scents or sounds were detected coming from the pump.Therefore, the root cause of the complaint cannot be determined.The pumps are 100% functional tested during incoming 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 110v (pump max).During the procedure, the pump max started smoking, making noises and smelling.The procedure was completed using the same pump max; however, the physician had to turn the pump max off and on multiple times throughout the procedure.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V
• Type of Device: JCX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5471004
• MDR Text Key: 39422907
• Report Number: 3005168196-2016-00259
• 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: Physician
• Type of Report: Initial
• Report Date: 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: PMX110
• Device Lot Number: F17857-15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1