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

Catalog Number PMX110

Device Problem Suction Problem (2170)

Patient Problem No Patient Involvement (2645)

Event Date 02/26/2019

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

During preparation for a medical procedure, the hospital staff noticed that the penumbra system aspiration pump max 110 (pump max) would turn on; however, it did not produce aspiration.The issue with the pump max was found prior to use and, therefore, was not used in the procedure.The procedure was completed using manual aspiration with a syringe.

Manufacturer Narrative

Please note that the following section was inadvertently missed on the initial mfr report and is being included on this follow-up #01 mfr report: 3005168196-2018-02492.Serial#.Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report: 3005168196-2018-02492.Device evaluated by manufacturer? reason for non-evaluation.Results code 1.Conclusion code 1.Results: dried blood was found inside the vacuum inlet nozzle.The blood found inside the vacuum inlet nozzle; therefore, functional testing could not be performed.Conclusions: evaluation of the returned pump max revealed dried blood inside the pump inlet nozzle.If the aspiration tubing is connected directly to the vacuum inlet nozzle instead of the canister supplied by penumbra, blood will likely be aspirated into the vacuum pump assembly.If fluid is aspirated into the vacuum pump assembly, the pump max may not function properly.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: 8453720
• MDR Text Key: 139957733
• Report Number: 3005168196-2019-00565
• 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: 01/01/2005,02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• 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: F16768-12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• 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: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1