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

Catalog Number PMX110

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 10/18/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the image of the serial number on the back of the penumbra system aspiration pump max 110 (pump max) was evaluated.The tubing to the regulator knob was twisted.Conclusion: evaluation of the returned pump max revealed that the regulator knob was damaged.The pump max was plugged in and powered on.While adjusting the vacuum pressure using the knob, the pressure was unable to be increased and decrease; however, once the knob was turned to maximum vacuum pressure the knob sprung towards the opposite direction.The pump max housing was removed by the penumbra investigator and it was observed that the tubing to the regulator knob was twisted.The tubing being twisted likely created the springiness that was felt during preparation.The kinked tubing also prevented the vacuum pressure from being adjusted during the functional analysis.Penumbra pumps are visually inspected and functionally tested during incoming inspection by quality.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 hospital staff found that the regulator knob of the pump max felt ¿springy¿, and when turned to maximum aspiration the knob had a tendency to turn in the opposite direction.The pump max was therefore not used, and the procedure was completed using a new pump max.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110
• Type of Device: JCX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7023015
• MDR Text Key: 92726954
• Report Number: 3005168196-2017-02023
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PMX110
• Device Lot Number: F12110-29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2014
• 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