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

Model Number PMX110

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2019

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the iliac vein using a penumbra system aspiration pump max 110 (pump max).During the procedure, the maximum vacuum pressure that the pump max generated was -22 mmhg.It was reported that this was not enough vacuum pressure to aspirate the thrombus; therefore, the pump max was disconnected.It was also reported that the pump max emitted a burning smell.The procedure was completed using a new pump max.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Additional information was added to: section e.Box 1: first name and postal code (zip).Results: the pump max was plugged in and powered on.The pump max was able to achieve a maximum vacuum pressure of -25in.Hg on the pump max gauge and the calibrated gauge.The pump max was powered on for 30 minutes and no burning smell was observed.Conclusions: evaluation of the returned pump max revealed a functional device.During the functional test, the pump max was plugged in and powered on.The pump max was able to achieve a vacuum pressure within specification.Therefore, the root cause of the reported complaint could not be determined.Penumbra pumps are 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.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9801880
• MDR Text Key: 188508954
• Report Number: 3005168196-2020-00304
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (y/n): Y
• PMA/PMN Number: K160533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/18/2019

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 Model Number: PMX110
• Device Catalogue Number: PMX110
• Device Lot Number: F13826-43
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• 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: 11/18/2019
• Initial Date FDA Received: 03/06/2020
• Supplement Dates Manufacturer Received: 05/18/2020
• Supplement Dates FDA Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 27 YR