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

Catalog Number PMX110

Device Problem Decrease in Suction (1146)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the pump max was powered on and able to produce a vacuum pressure of approximately -28.5 inhg.Conclusions: evaluation of the returned pump max revealed a device capable of producing sufficient vacuum pressure.The pump max was able to power on and generate a vacuum pressure within specification.The regulator knob was able to regulate vacuum pressure as intended.The reported smell and weak aspiration power was unable to be confirmed.Penumbra pumps are visually inspected and functionally tested during incoming quality 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 physician noticed that the pump max smelled hot and that the aspiration power didn¿t seem very strong.The procedure was completed using the same pump max.There was no report of an adverse effect to the patient.The actual event dates are unknown.

• 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: 7791281
• MDR Text Key: 117432648
• Report Number: 3005168196-2018-01607
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (y/n): Y
• 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,Followup
• Report Date: 01/01/2005,07/19/2018

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: Health Professional
• Device Catalogue Number: PMX110
• Device Lot Number: F34081-33
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 08/16/2018
• Supplement Dates Manufacturer Received: 07/19/2018
• Supplement Dates FDA Received: 08/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2018
• 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