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	10/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is pending 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 m1 segment of the middle cerebral artery (mca) using a penumbra system aspiration pump max 220 (pump max).During the procedure, the pump max stopped working.It was reported that the motor would not run despite that the pump max was powered on.Therefore, the pump max was not used for the remainder of the procedure.The procedure was completed using another pump max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the regulator know was loose from the pump's housing.A pipe cleaner was inserted into the vacuum inlet and blood was observed.Conclusions: evaluation of the returned pump max revealed blood was aspirated into the pump.If the tubing is connected directly to the vacuum inlet instead of the canister, supplied by penumbra, blood may be aspirated into the pump.If this occurs, the pump may not function properly.Further evaluation revealed a loose regulator knob.This damage was likely incidental to the reported complaint, and typically occurs if the regulator knob is excessively rotated.Penumbra pumps are 100% visually inspected and functionally tested during incoming quality inspection.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.H3 other text : placeholder.

• 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: 9269667
• Report Number: 3005168196-2019-02036
• Device Sequence Number: 1872590
• Product Code: NRY
• UDI-Device Identifier: 00814548012698
• UDI-Public: 00814548012698
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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): 10/04/2019
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 02/04/2020
• 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