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

Catalog Number PMX220

Device Problems Failure to Pump (1502); Device Operates Differently Than Expected (2913); No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2016

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

The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 220v (pump max).During the procedure, the pump max was turned on and ready for use; however, a sudden electric circuit shock occurred, which caused a power outage.When the electricity came back on, the pump max was switched on again but was unable to produce any vacuum.Therefore, the procedure was completed using another manufacturer's device.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Result: blood was found in and around the vacuum inlet on the top of the pump.A pipe cleaner was inserted in the pump inlet and fluid was observed inside the pump.Conclusion: evaluation of the returned pump revealed blood in and around the pump vacuum inlet.A pipe cleaner was inserted in the pump inlet and fluid was observed inside the pump.If the aspiration tubing connected directly to the vacuum inlet rather than the canister supplied by penumbra, blood or other fluid will likely enter the pump assembly.The observed blood likely contributed to the pump not producing vacuum.Penumbra pumps are visually and functionally inspected during incoming quality inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The event description has been modified as follows: the patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 220v (pump max).During the procedure, the pump max was turned on and ready for use; however, a power outage occurred.When the electricity came back on, the pump max was switched on again but was unable to produce any vacuum.Therefore, the procedure was completed using another manufacturer's device.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V
• Type of Device: JCX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5834563
• MDR Text Key: 50817634
• Report Number: 3005168196-2016-01094
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00814548012698
• UDI-Public: 00814548012698
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K122756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: PMX220
• Device Lot Number: F15888-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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
• Patient Age: 67 YR