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

Catalog Number	PMX110
Medical Device Problem Codes	Misconnection (1399); Use of Device Problem (1670); Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: a pipe cleaner was inserted into the pump max vacuum inlet and dried blood was observed inside the vacuum tubing.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 vacuum inlet instead of the canister and blood was aspirated into the pump.If the aspiration tubing is connected to the vacuum inlet instead of the canister supplied by penumbra, fluid will likely be aspirated into the vacuum assembly and 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.
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 aspiration tubing (tubing) was inadvertently connected directly to the pump max rather than the canister.Consequently, blood was aspirated into the pump max.However, the physician decided to use the same pump max to complete the procedure.There was no report of an adverse effect to the patient.

• 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: 8822456
• Report Number: 3005168196-2019-01433
• Device Sequence Number: 19647944
• Product Code: DXE
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160533
• 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
• Report Date (Section B): 06/25/2019
• 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: F28208-22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/24/2019
• 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