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

Catalog Number PMX110

Device Problem Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/31/2018

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 110 (pump max).During the procedure, the physician turned the pump max off in order to unclog the catheter and tubing; however, while attempting to turn the pump max back on, it would not turn on right away.The power button required to be pushed several times before the pump max would turn on and it sounded like it could stall out.The negative pressure was sustained, and the procedure was completed using the same pump max.There was no report of an adverse effect on the patient.

Manufacturer Narrative

Results: the pump max was able to power on and produce a vacuum pressure of approximately -28.5 inhg.During the functional testing, power button was turned on and off several times and no issue was found.Conclusions: evaluation of the returned pump max revealed a functional device that produced a vacuum pressure within specification.The reported complaint stated that the pump max was powered off, and on again while under vacuum pressure.If the pump max powered off while experiencing vacuum pressure, the vacuum pump may not be able to turn on again until the vacuum pressure is equalized.During functional testing the power button was turned on and off several times and the pump was able to power on and off without any issue.The reported inability to power on and unusual sound were unable to be confirmed.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: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8320874
• MDR Text Key: 135573763
• Report Number: 3005168196-2019-00209
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (y/n): Y
• PMA/PMN Number: K160533
• 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: 01/01/2005,01/09/2019

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: F34081-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• 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: 01/09/2019
• Initial Date FDA Received: 02/08/2019
• Supplement Dates Manufacturer Received: 04/05/2019
• Supplement Dates FDA Received: 05/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR