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

Catalog Number PMX110

Device Problems Contamination (1120); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2018

Event Type  malfunction  

Manufacturer Narrative

Results: dried blood was present on the device housing.Blood was present inside the vacuum pump; therefore, functional testing was not performed.Conclusions: evaluation of the returned pump max confirmed a device with blood inside the vacuum pump.This is likely a result of the reported incorrect connection of the aspiration tubing directly to the vacuum inlet instead of the canister supplied by penumbra.If fluid enters the vacuum pump, it may prevent the pump from functioning properly.Penumbra pumps are visually inspected and functionally test during incoming quality inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 110v (pump max).During the procedure, a hospital staff accidentally connected an indigo system aspiration catheter d (catd) directly to the pump max rather than the canister.Consequently, blood was aspirated into the pump max; therefore, it was disconnected.The procedure was completed using a standard balloon angioplasty.It should be noted that there was no noted damage to the catd.Additionally, there was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7939151
• MDR Text Key: 123411158
• Report Number: 3005168196-2018-01942
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K160533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PMX110
• Device Lot Number: F39387-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 09/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 20 YR