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

Catalog Number PMX110

Device Problems Aspiration Issue (2883); No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2016

Event Type  malfunction  

Manufacturer Narrative

Results: the penumbra system aspiration pump max 110v (pump max) was opened by a penumbra investigator and slight corrosion was observed on the piston crown in the outlet cylinder.Conclusions: evaluation of the returned device revealed that the pump was functional.The pump was plugged in and powered on and vacuum was generated.The pump may present difficulty turning on when under vacuum.The vacuum pressure may have to decrease prior to restarting the pump.The pump was opened by the penumbra investigator and slight corrosion was observed.The observed corrosion was likely incidental and unrelated to the reported events.Evaluation of the tubing revealed that the returned portion was functional.The tubing was flushed with fluid and air during decontamination without an issue.Since only a portion of the tubing was returned for evaluation, the root cause of the reported event could not be confirmed.Penumbra pumps are visually and functionally inspected during incoming quality inspection.Penumbra tubing is visually inspected during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2016-01605.

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 110v (pump max) and the indigo system aspiration tubing (tubing).During the procedure, the pump max was powered on and the green power button illuminated but the pump max was unable to create vacuum.In addition, the physician noticed that the valve on the tubing would not open.The technician then changed out the tubing for a new penumbra system aspiration tubing (new tubing) and unplugged the pump max several times.After about three minutes or so, the pump max was able to produce vacuum through the new tubing.Therefore, the procedure was completed using the same pump max and the new tubing.There was no report of an 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: 6096069
• MDR Text Key: 59765828
• Report Number: 3005168196-2016-01604
• 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: Physician
• Type of Report: Initial
• Report Date: 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: PMX110
• Device Lot Number: F07119-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2014
• 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: 55 YR