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

Catalog Number	PMX110
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: dried blood was observed on the pump housing.Conclusions: evaluation of the returned pump max confirmed that the blood was aspirated into the pump vacuum system.The complaint indicated that an aspiration tubing was connected directly to the vacuum inlet rather that the canister supplied by penumbra.Subsequently, blood entered the pump assembly.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, a hospital staff accidentally connected the aspiration tubing (tubing) directly to the pump max rather than the canister.Consequently, blood was aspirated into the pump max; therefore, the pump max was not used.The procedure was completed using a non-penumbra stent retriever.There was no report of an adverse effect to the patient.

• 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: 9506395
• Report Number: 3005168196-2019-02366
• Device Sequence Number: 13779105
• Product Code: NRY
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• 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
• Report Date (Section B): 11/24/2019
• 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: F14586-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• 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: 11/24/2019
• Initial Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Date Report Sent to FDA: 01/01/2005