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

Catalog Number PMX220

Device Problems Device Emits Odor (1425); Aspiration Issue (2883); No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2015

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 using a penumbra system aspiration pump max 220 (pump max).During the procedure, the pump max was not producing vacuum and also emitted a "strange" smell.The procedure continued using an indigo system aspiration catheter 5 with a syringe.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Result: there was no visible damage to the exterior of the penumbra aspiration pump (pump).The pump was plugged in and powered on.The pump only made a humming sound like a fan was running.A burning smell was observed after approximately 5 minutes of the pump being on.However, the pump was powered on for further evaluation at a later instance, and functioned as intended.Conclusion: evaluation of the returned pump revealed that upon powering on, a humming noise was heard, but no vacuum pressure could be created.A burning smell was observed after approximately 5 minutes of the pump being on.The pump was powered on for further evaluation at a later instance, and functioned as intended.The pump did not work properly in all instances and, therefore, the pump was nonfunctional.The root cause of this complaint cannot be determined.Pumps are 100% 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
• Type of Device: JCX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5186424
• MDR Text Key: 29800186
• Report Number: 3005168196-2015-01110
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00814548012698
• UDI-Public: 00814548012698
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: PMX220
• Device Lot Number: F15286-27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1