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

Catalog Number PMX110

Device Problems Device Damaged Prior to Use (2284); Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 01/25/2019

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 thrombectomy procedure, the hospital staff noticed that the power inlet on the back of a penumbra system aspiration pump max 110 (pump max) was broken.The damage to the pump max was found prior to use and, therefore, it was not used in the procedure.The procedure was completed using a different pump max.

Manufacturer Narrative

Results: the power inlet was detached from the penumbra system aspiration pump max 110 (pump max) housing.Conclusions: evaluation of the returned pump max revealed that the power inlet on the back of the pump housing was detached.If the back of the pump max is impacted while the plug is inside the power inlet, damage such as the inlet may become loose from the pump housing.Subsequently, upon removal of the plug, the power inlet may become detached from the pump housing.Penumbra pumps are visually inspected and functionally tested during incoming inspection by quality.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: JCX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8373827
• MDR Text Key: 137276590
• Report Number: 3005168196-2019-00363
• 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: 01/01/2005,01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• 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: F19969-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• 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