MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 220; NRY

Model Number	PMX220
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2019
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 to treat a fistula using a penumbra system aspiration pump max 220 (pump max).During the procedure, the physician reported that the pump max was low, irregular, and continued to stop.The procedure was completed using the same pump max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the regulator knob was loose from the pump housing.Conclusions: evaluation of the returned pump max revealed a functional device.During functional testing, the pump max was powered on and was able to achieve a vacuum pressure within specification.The pump was then run continuously for 30 minutes without issue.The reported complaint could not be confirmed.Further evaluation revealed that the regulator knob was loose from the pump housing.This damage was likely incidental to the reported complaint and typically occurs if the regulator knob is over rotated.Penumbra pumps are 100% 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.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 220
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9536258
• Report Number: 3005168196-2019-02435
• Device Sequence Number: 2353539
• Product Code: NRY
• UDI-Device Identifier: 00814548012698
• UDI-Public: 00814548012698
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2019
• 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: PMX220
• Device Catalogue Number: PMX220
• Device Lot Number: F20592-35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 12/31/2019
• Supplement Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005