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

Catalog Number PMX220

Device Problems Suction Problem (2170); Aspiration Issue (2883); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2017

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 in the right internal carotid artery (ica) using a penumbra system aspiration pump max 220 (pump max).During the procedures, the hospital staff noticed that the pump max was unable to remain powered on unless the power button was held down, and, additionally, it was noticed that the pump max was unable to create adequate suction, even when it remained on.The procedure was therefore completed using a manual syringe.There was no report of an adverse effect to the patients.

Manufacturer Narrative

Results: the pump max was plugged in and powered on; however, the power button would not stay depressed.However, the pump was able to reach full vacuum pressure.Conclusions: evaluation of the returned device confirmed that the penumbra system aspiration pump max 220v (pump max) power button would not stay depressed.The pump max was plugged in an attempted to be powered on; however, the power button would not stay depressed.In addition the pump max was able to create adequate vacuum pressure, while the power button was held down.The root cause of the button not remaining depressed could not be determined.Penumbra pumps are visually inspected and functionally tested during incoming inspection by quality.Update on 23 aug 2017 for the supplier revealed that the received condition of the pump max housing (i.E.Crack located on the top housing, missing power button cover) indicates that the power button could have been contributed to the pump being mishandled (dropped), thus causing the power button to be nonfunctional.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: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 6555776
• MDR Text Key: 74795868
• Report Number: 3005168196-2017-00713
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012698
• UDI-Public: 00814548012698
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K122756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2017

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: Physician
• Device Catalogue Number: PMX220
• Device Lot Number: F21927-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2017
• Initial Date FDA Received: 05/09/2017
• Supplement Dates Manufacturer Received: 08/23/2017; 08/23/2017
• Supplement Dates FDA Received: 09/19/2017; 09/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 60 YR