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

Catalog Number PMX110

Device Problem Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2018

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

The patient was undergoing a medical procedure using a penumbra system aspiration pump max 110 (pump max).During the procedure, the hospital staff noticed the pump max would turn on and then turn off.The hospital staff was able to turn the pump max on again momentarily, but it turned off again and would not turn back on.The procedure was completed using the same pump max and manual aspiration.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Additional information: please note that the following section was inadvertently missed and is being updated on this follow up #3005168196-2019-00148 mfr report: serial number.Results: the returned pump max was able to power on and produce a vacuum pressure of approximately -29.0 inhg.The pump max was run continuously for 15 minutes without interruption.Conclusions: evaluation of the returned pump max revealed a fully functional device.During the functional testing, the pump max was powered on and able to produce a vacuum pressure within specification for 15 minutes without interruption.The pump power switch was turned on and turned off a few times and the pump ran without issue.The reported complaint could not be determined.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.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110
• Type of Device: JCX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8278928
• MDR Text Key: 134180931
• Report Number: 3005168196-2019-00148
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (y/n): Y
• PMA/PMN Number: K122756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• 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: F21721-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• 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: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1