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

Catalog Number PMX110

Device Problems Misconnection (1399); Device Contamination with Body Fluid (2317); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the pump max had blood on the exterior of the pump housing.The pump max power inlet was broken.Conclusions: evaluation of the returned pump max revealed blood inside the pump max.If the aspiration tubing is connected directly to the vacuum inlet rather than the canister supplied by penumbra, blood may be aspirated into the pump max.Further evaluation revealed that the power inlet on the back of the pump max was damaged.This damage was likely incidental to the reported issue and may have occurred while packaging the pump for return to penumbra.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 Description

The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 110v (pump max).During the procedure, the 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.The procedure was completed using another pump max.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110
• 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: 7928721
• MDR Text Key: 122459047
• Report Number: 3005168196-2018-01939
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,09/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• 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: F07792-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• 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: 09/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2012
• 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: 17 YR