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

Model Number	PMX110
Medical Device Problem Codes	Suction Problem (2170); Suction Failure (4039)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10347994
• Report Number: 3005168196-2020-01061
• Device Sequence Number: 13659144
• Product Code: DXE
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2020
• Report Date (Section F): 01/01/2005

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
• Operator of Device: 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 to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005