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

Catalog Number PMX110

Device Problems Pumping Stopped (1503); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/31/2017

Event Type  malfunction  

Manufacturer Narrative

Results: a pipe cleaner was inserted into the penumbra system aspiration pump max 110 (pump max) vacuum port, and blood was observed to be inside the pump.Conclusion: evaluation of the returned device revealed that the pump max had blood inside.This type of damage typically occurs due to improper handling during use.If the aspiration tubing is connected directly to the vacuum inlet rather than the canister supplied by penumbra, blood will likely enter the pump assembly.The blood inside the pump max likely caused the pump max to stop working during the procedure.Penumbra pumps are visually inspected and 100% functionally tested during incoming inspection by quality.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 penumbra system aspiration pump max 110 (pump max).During the procedure, the pump max stopped working.Although there was no report of an adverse effect on the patient, multiple attempts have been made to gather additional information.As of 25-sept-2017, no additional information is available.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110
• Type of Device: JCX
• 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: 6892212
• MDR Text Key: 89257130
• Report Number: 3005168196-2017-01646
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• 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: F07836-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2013
• 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