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

Catalog Number PMX220

Device Problems Aspiration Issue (2883); Pressure Problem (3012); Pumping Problem (3016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2016

Event Type  malfunction  

Manufacturer Narrative

The penumbra system aspiration pump max 220v (pump max) was plugged in and powered on and max vacuum was generated.However, the vacuum pressure could not be increased or decreased by turning the regulator knob.Evaluation of the returned pump max confirmed that the vacuum pressure could not be increased or modified.The pump was plugged in and powered on and max vacuum was generated.However, the vacuum pressure could not be increased or decreased during the functional analysis by turning the regulator knob.The root cause of this complaint could not be determined.All penumbra pumps are visually and functionally inspected during incoming quality inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 220v (pump max).During the procedure, while attempting to initiate aspiration, the pump max did not produce adequate vacuum and the physician was unable to increase or modify the level of suction.Therefore, the procedure was completed using a new pump max.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Further evaluation from penumbra supplier quality engineers revealed that if the regulator knob is rotated beyond the intended limit, then the washer may lose grip and cause the hex nut to back out.Therefore, the root cause of this complaint is a loose hex nut due to user error.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V
• Type of Device: JCX
• 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: 6091049
• MDR Text Key: 59578161
• Report Number: 3005168196-2016-01586
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00814548012698
• UDI-Public: 00814548012698
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K122756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: PMX220
• Device Lot Number: F06781-36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2013
• 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