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

Catalog Number PMX220

Device Problems Suction Problem (2170); Complete Loss of Power (4015)

Patient Problem No Patient Involvement (2645)

Event Date 04/18/2019

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2019-00976.

Event Description

During preparation for a medical procedure using a penumbra system aspiration pump max 220 (pump max), the pump max would not power on or produce vacuum.The issue with the pump max was found prior to use and therefore, the pump max was not used in the procedure.A second pump max was then used; however, it was reported that this pump max produced vacuum but aspirated inconsistently.The physician was able to manage the issue with the second pump max and it was used to complete the procedure.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the pump power inlet was damaged.Conclusions: evaluation of the first pump max revealed that the power inlet was damaged.If the back of the pump is impacted while the power cord is plugged in, the power inlet may become damaged.During functional testing, the pump was able to power on and produce the vacuum pressure within specification.The reported power issue could not be confirmed.Evaluation of the second pump max revealed a functional device.During the functional testing, the pump max was powered on and able to produce a vacuum pressure within specification.The pump was continually running for approximately 30 min without issue.The reported inconsistent aspiration could not 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.This report is associated with mfr report number: 1.(b)(4).H3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 220
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8620574
• MDR Text Key: 145403811
• Report Number: 3005168196-2019-00975
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012698
• UDI-Public: 00814548012698
• Combination Product (y/n): Y
• PMA/PMN Number: K160449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,04/18/2019

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: PMX220
• Device Lot Number: F16550-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• 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: 04/18/2019
• Initial Date FDA Received: 05/17/2019
• Supplement Dates Manufacturer Received: 07/22/2019
• Supplement Dates FDA Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1