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

Model Number	PMX220
Medical Device Problem Codes	Misconnection (1399); Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/23/2019
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 220 (pump max).During the procedure, the aspiration tubing (tubing) was accidentally connected directly to the pump max rather than the indigo pump max canister (canister).Consequently, fluid was aspirated into the pump max and it started smoking and shut down.Therefore, the pump max was removed.The procedure was completed using manual aspiration.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: a pipe cleaner was inserted into the pump max vacuum inlet and no presence of fluid was detected.The device housing was opened, and fluid was found within the vacuum tubing.Fluid residue was found within the device housing.Conclusions: evaluation of the returned pump max confirmed fluid within the device.If the tubing is connected directly to the vacuum inlet, fluid may aspirate into the pump max.If fluid is aspirated into the device, the pump max may not function properly.Penumbra 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 h3 other text : placeholder.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #02 mfr report:3005168196-2019-01040.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 220
• Common Device Name: JCX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8645837
• Report Number: 3005168196-2019-01040
• Device Sequence Number: 11264025
• Product Code: JCX
• UDI-Device Identifier: 00814548012698
• UDI-Public: 00814548012698
• Combination Product (Y/N): Y
• Initial Reporter Country: NL
• PMA/510(K) Number: K122756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2019
• 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: PMX220
• Device Catalogue Number: PMX220
• Device Lot Number: F23725-12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 07/09/2019; 01/14/2005
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 08/08/2019; 05/01/2020
• 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