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

Model Number PMX110

Device Problems Suction Problem (2170); Suction Failure (4039)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2020

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

The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 110 (pump max).During the procedure, the hospital staff noticed that the pump max did not generate vacuum pressure.An attempt was made to troubleshoot the pump max but was unsuccessful.It was reported that the regulatory knob was loose, spinning and not catching on the dial.Subsequently, not allowing the vacuum pressure to be adjusted upward.Therefore, the pump max was disconnected.The physician decided to abandon the thrombus aspiration and opted to angioplasty.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: dried blood was observed on the pump housing.The regulator knob was undamaged.Conclusions: evaluation of the returned pump max revealed that blood was aspirated inside its vacuum assembly.If the aspiration tubing is connected directly to the vacuum inlet instead of the canister, supplied by penumbra, blood will likely be aspirated into the vacuum assembly.If fluid is aspirated into the vacuum assembly, the pump may not function properly.The regulator knob was visually inspected, and no damage was observed.Therefore, the reported regulator knob damage 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.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10347994
• MDR Text Key: 201229348
• Report Number: 3005168196-2020-01061
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (y/n): Y
• PMA/PMN Number: K161506
• 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: 01/01/2005,07/09/2020

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 Model Number: PMX110
• Device Catalogue Number: PMX110
• Device Lot Number: F43007-18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• 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: 07/09/2020
• Initial Date FDA Received: 07/30/2020
• Supplement Dates Manufacturer Received: 08/04/2020
• Supplement Dates FDA Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1