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

Catalog Number PMX220

Device Problems Failure to Pump (1502); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 07/27/2018

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 the procedure, the technician found that the penumbra system aspiration pump max 220 (pump max) would not turn on and, therefore, it was not used in the procedure.The procedure was completed using manual aspiration.

Manufacturer Narrative

Results: a pipe cleaner was inserted into the vacuum inlet and blood was present.Conclusions: evaluation of the returned pump max revealed that the pump had blood inside the vacuum inlet.If the aspiration tubing is connected directly to the vacuum inlet rather than the pump canister, supplied by penumbra, blood will likely be aspirated directly into the vacuum assembly.Fluid being aspirated into the pump likely contributed to the pump not producing aspiration.During the functional test, the pump max was powered on and the fan ran but no aspiration was observed.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 220V
• Type of Device: JCX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7980690
• MDR Text Key: 124322906
• Report Number: 3005168196-2018-02052
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00814548012698
• UDI-Public: 00814548012698
• Combination Product (y/n): Y
• PMA/PMN Number: K122756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• 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: F27976-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• 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: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1