MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V; JCX

Catalog Number PMX220

Device Problems Device Operational Issue (2914); No Pressure (2994); Pumping Problem (3016)

Patient Problem No Patient Involvement (2645)

Event Date 02/10/2016

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

During preparation for a thrombectomy procedure, the hospital staff noticed that when the penumbra system aspiration pump max 220v (pump max) was turned on, only the fan made a faint noise; no vacuum was produced and there was no pressure reading.The defective pump max was found prior to use and was not used during the procedure.The procedure was completed using a stent retriever.

Manufacturer Narrative

There was no visible damage to the exterior of the pump.The pump was plugged in and powered on.The vacuum pump did not start; only the pump cooling fan started.The pump was opened by penumbra engineers and corrosion was observed on the piston crown in the outlet cylinder.Evaluation of the returned pump confirmed that even though power was supplied to the pump, the vacuum pump would not turn on.The pump housing was removed, and the vacuum pump was opened by penumbra engineers.It was observed that the piston crown in the outlet cylinder was corroded.The observed corrosion likely caused the piston to seize inside the cylinder.The root cause of this corrosion could not be determined.Penumbra pumps are 100% 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.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V
• Type of Device: JCX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5491171
• MDR Text Key: 40027486
• Report Number: 3005168196-2016-00299
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00814548012698
• UDI-Public: 00814548012698
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K122756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PMX220
• Device Lot Number: F11088-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2014
• 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