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

Catalog Number	PMX110
Medical Device Problem Codes	Contamination (1120); Misconnection (1399); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 110 (pump max).During the procedure, the pump max was inadvertently set up incorrectly and, consequently, saline was aspirated into the body of the pump max rather than the indigo pump max canister (canister).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 pump housing was opened and dried blood was found inside the housing.The blood was found inside the pump assembly; therefore, no functional testing performed.Conclusions: evaluation of the returned pump max confirmed blood was aspirated inside the vacuum pump.The reported complaint indicated that the aspiration tubing was directly connected to the pump inlet instead of the canister, supplied by penumbra, and fluid was aspirated into the pump.If the fluid enters the vacuum pump assembly, the pump may not function properly.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.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8458178
• Report Number: 3005168196-2019-00599
• Device Sequence Number: 429111
• Product Code: NRY
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (Y/N): Y
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2019
• 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 Catalogue Number: PMX110
• Device Lot Number: F29248-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/01/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Date Report Sent to FDA: 01/01/2005