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

Catalog Number	PMX220
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a medical procedure in the middle cerebral artery (mca) using a penumbra system aspiration pump max 220v (pump max).During the procedure, while connecting the pump to the power circuit, a short circuit occurred causing the power in the catheterization laboratory to shut off.The procedure was completed using manual aspiration with a syringe to remove the clot from the mca.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the initial mfr report and is being updated on this follow-up # 01 mfr report: 3005168196-2019-01419.Results: the device housing was opened and found that the two wires from the power switch had damaged insulation.Conclusions: evaluation of the returned pump max confirmed a short circuit.During the functional testing, an electrical short circuit occurred when the pump max was turned on.Subsequently, all of the fuses of the pump max and the power supply became damaged.During functional testing, the pump housing was opened and found that the two wires from the power switch had damaged insulation.The damage power cords were determined to be the cause of the short circuit and the reported complaint.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 220
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8812270
• Report Number: 3005168196-2019-01419
• Device Sequence Number: 14159102
• Product Code: NRY
• UDI-Device Identifier: 00814548012698
• UDI-Public: 00814548012698
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2019
• 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 Catalogue Number: PMX220
• Device Lot Number: F23319-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/22/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 10/18/2019
• 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