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

Catalog Number PMX110

Device Problems Pressure Problem (3012); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the pump max was able to reach a vacuum pressure of approximately -30.0 inhg on the gauge attached to the pump housing and approximately -29.0 inhg on the calibrated gauge.The pump max was plugged in and powered on and ran under full vacuum for approximately 25 minutes.The pump max functioned without an issue.No unusual sounds were observed during the functional test.Conclusions: evaluation of the returned pump max revealed that the pump was functional.The pump max was plugged in and powered on and ran under full vacuum.The pump functioned without an issue.There was no unusual sounds observed during the functional test.The root cause of the pump not aspirating with full strength, and the pump sounding like a car running out of gas could not be determined.Penumbra pumps are visually inspected during in-process inspection and during quality inspection after manufacturing.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 medical procedure using a penumbra system aspiration pump max 110 (pump max).During the procedure, the physician observed that the pump max was not aspirating with full strength.It was also reported that the pump max was making unusual noises, which sounded like a car running out of gas.The procedure was completed using another pump max.There was no adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V
• 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: 8053735
• MDR Text Key: 127343416
• Report Number: 3005168196-2018-02206
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (y/n): Y
• 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: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,10/09/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: PMX110
• Device Lot Number: F25371-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• 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
• Initial Date Manufacturer Received: 10/09/2018
• Initial Date FDA Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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