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

Catalog Number PMX110

Device Problems Device Operational Issue (2914); No Pressure (2994)

Patient Problem No Patient Involvement (2645)

Event Date 01/13/2016

Event Type  malfunction  

Manufacturer Narrative

Results: there was no visible damage to the exterior of the pump.Conclusions: evaluation of the returned device revealed that the pump was fully functional.During functional testing, the pump was plugged in, powered on, and power cycled multiple times.The pump was able to produce fully adjustable vacuum.The root cause of this complaint could not be determined.Penumbra 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

During preparation for a thrombectomy procedure, the penumbra system aspiration pump max 110v (pump max) was powered on and the motor made a quiet noise; however, no vacuum was produced.The defective pump max was found prior to use and was not used for the procedure.The procedure continued using a new pump max.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110
• 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: 5427507
• MDR Text Key: 37982197
• Report Number: 3005168196-2016-00156
• 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
• Type of Report: Initial
• Report Date: 01/13/2016

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: PMX110
• Device Lot Number: F17857-31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/13/2016
• Initial Date FDA Received: 02/10/2016
• 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