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

Catalog Number PMX220

Device Problems Defective Device (2588); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2018

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

The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 220 (pump max).During the procedure, the pump max was accidentally dropped on the floor and consequently, the power inlet became faulty; therefore, the pump max was disconnected.The procedure was completed successfully with a non-penumbra catheter and there was no adverse effect to the patient.

Manufacturer Narrative

Results: the power inlet of the pump max was cracked and pushed in.The back of the pump max had a crack.The pump max had clear tape holding the pump together.After opening the pump max, it was noticed that the one of the cables was detached from the power inlet.The fuse box was also loose and would not stay in on its own.After reconnecting the detached cable and attempting to power on the device, there was no aspiration.Aspiration only occurred when the penumbra investigator applied pressure to the loose fuse box.When the pump max was powered on, it was able to achieve a vacuum pressure of approximately -28.0 in hg.Conclusions: evaluation of the returned pump max revealed a device with a damaged power inlet that was unable to produce sufficient vacuum pressure.The power inlet and device housing had cracks and the fuse box was loose from the power inlet.During functional testing, the pump max was unable to power on.Once the penumbra investigator reconnected a detached cable and applied pressure to the loose fusebox, the pump max was able to power on and produce a vacuum pressure within specification.The damage to the pump max was likely due to the reported dropping of the pump max onto the floor.Penumbra aspiration pumps are 100% 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 220V
• Type of Device: JCX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8001683
• MDR Text Key: 124974920
• Report Number: 3005168196-2018-02127
• 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: 01/01/2005,09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• 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: F28440-23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• 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: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR