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

Catalog Number PMX110

Device Problems Decrease in Suction (1146); Device Emits Odor (1425); Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2016-00696.

Event Description

The patient was undergoing a thrombectomy procedure using an indigo system separator 8 (sep8) and a penumbra system aspiration pump max 110v (pump max).During the procedure, the physician was unable to backload the torque device onto the sep8.Therefore, it was removed and a new sep8 was used to continue the procedure.While in use, the pump max became very heated and emitted a burnt smell.It was also noticed that the pump max stopped producing vacuum throughout the procedure as the vacuum gauge went from -21 inhg down to 0.The physician turned off the pump max to let the device cool.Upon turning the pump max back on, the physician noticed that the pump max was quiet and was not making the usual fan noise.Therefore, the procedure was completed using a second pump max.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Result: there was no visible damage to the penumbra system aspiration pump max 110v (pump max).The pump max was plugged in, powered on, and ran for 30 minutes, and no issues were found.Therefore, the pump max was functional.Conclusion: evaluation of the returned device revealed that the indigo system separator 8 (sep8) original torque device was able to be back loaded on the proximal end of the sep8 delivery wire.Therefore, the root of this issue could not be determined.Evaluation of the returned device revealed that the pump max was functional.The pump max was plugged in and powered on and ran for 30 minutes and no issue was found.The burning smell mentioned in the complaint could not be confirmed.Therefore, the root cause of this complaint could not be determined.Sep8s are 100% dimensionally inspected during in-process inspection.Pump maxs are 100% functionally tested during incoming inspection.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 110V
• Type of Device: JCX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5669756
• MDR Text Key: 45608831
• Report Number: 3005168196-2016-00695
• 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,Followup
• Report Date: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: PMX110
• Device Lot Number: F18683-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2015
• 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: 92 YR