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

Catalog Number PMX110

Device Problems Aspiration Issue (2883); Device Operates Differently Than Expected (2913); No Pressure (2994)

Patient Problem No Patient Involvement (2645)

Event Date 01/26/2018

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

During preparation for a thrombectomy procedure, the penumbra system aspiration pump max 110v (pump max) was powered on with the on/off button illuminated green; however, the pump max was unable to produce any vacuum.Therefore, the physician decided to only do a diagnostic and postponed the procedure.

Manufacturer Narrative

Results: the pump max was unable to be opened conventionally.The pump max was opened forcefully damaging some of the screw anchors.The interior of the device revealed unidentified black and yellow liquid residues throughout the pump housing and device components.The capacitor was found unscrewed and free from its housing.Yellow residue was found on the screw mounting holes and exiting the cooling fan air intake.Conclusions: evaluation of the returned pump max confirmed the device was unable to produce aspiration.The pump max housing was forcefully opened and liquid residues were found throughout the device.The capacitor was covered in a black grease-like substance and loose from its housing.If the capacitor was compromised, it would likely contribute to the inability of the pump assembly to power on and produce aspiration.The returned condition discovered inside the pump housing suggests the device was likely stored and cared for poorly.It is possible the device was opened and tampered with.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 110V
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7290750
• MDR Text Key: 100793226
• Report Number: 3005168196-2018-00306
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K160533
• 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,Followup
• Report Date: 01/01/2005,01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: PMX110
• Device Lot Number: F19969-36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• 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
• Date Manufacturer Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1