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

Catalog Number PMX110

Device Problems Device Emits Odor (1425); No Pressure (2994)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 10/05/2015

Event Type  malfunction  

Manufacturer Narrative

Results: there was no visible damage to the exterior of the penumbra system aspiration pump max 110 (pump max).The pump max was powered on and was able to reach a full vacuum.The pump was run for 30 minutes without issue.Conclusions: evaluation of the returned device revealed that upon powering on, the pump could reach a vacuum pressure within specification.In addition, no burning smell was observed by the penumbra investigator.The pump functioned as intended, and the root cause of the complaint could not be determined.These devices are 100% functionally tested during 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 110 (pump max).During preparation for the procedure, the pump max was turned on but no vacuum was produced.The physician reconnected the power cord and switched the pump max on again but it still did not create a vacuum.The physician noticed a "burnt" smell coming from the pump max and decided not to use it for the procedure.The procedure continued using another manufacturer's device.There was no report of an adverse effect to the patient.

Event Description

During preparation for a thrombectomy procedure, the physician turned on the penumbra system aspiration pump max 110v (pump max); however, no vacuum was produced.The physician then reconnected the power cord and switched on the pump max again but there was still no vacuum.Subsequently, a burning smell was coming from the pump max.Therefore, the pump max was not used in the procedure and the procedure was completed using another device.

• 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: 5233317
• MDR Text Key: 31511529
• Report Number: 3005168196-2015-01165
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2015

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: F13929-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2015
• Initial Date FDA Received: 11/18/2015
• Supplement Dates Manufacturer Received: 10/20/2015
• Supplement Dates FDA Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2014
• 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