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

Model Number	PMX110
Medical Device Problem Codes	Decrease in Suction (1146); Device Emits Odor (1425)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem 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.
Additional 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
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9801880
• Report Number: 3005168196-2020-00304
• Device Sequence Number: 13613756
• Product Code: DXE
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• PMA/510(K) Number: K160533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2019
• Report Date (Section F): 01/01/2005

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
• Operator of Device: 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 to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 06/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Date Report Sent to FDA: 01/01/2005