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

Catalog Number PMX220

Device Problems Device Emits Odor (1425); No Pressure (2994); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2016

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 220v (pump max).During the procedure, the pump max made a strange sound and did not produce vacuum.It was also reported that a burnt smell arose from the pump max.Therefore, the pump max was disconnected and the procedure was successfully completed by manual aspiration using the penumbra system ace 64 reperfusion catheter (ace 64).There was no report of an adverse effect to the patient.

Manufacturer Narrative

Usage of device was incorrectly reported on the initial mfr.Report and is being corrected on this follow-up #1 mfr report.Results: upon moving the top biohazard bag, blood was visible on the penumbra system aspiration pump max 220v (pump max).Removal of the biohazard bags revealed blood had soaked the handle and casing.In addition, dried blood was found in and around the vacuum inlet on the top of the pump.The penumbra investigator opened the pump and found blood throughout the vacuum tubing.Conclusions: evaluation of the pump revealed blood in and around the pump vacuum inlet.Upon opening the device, blood was observed within the pump assembly.If the aspiration tubing is connected directly to the vacuum inlet rather than the canister supplied by penumbra, blood will likely enter the pump assembly.The observed blood likely contributed to the reported strange sound and burnt smell.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.

• 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: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5939454
• MDR Text Key: 54316549
• Report Number: 3005168196-2016-01301
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00814548012698
• UDI-Public: 00814548012698
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 08/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: PMX220
• Device Lot Number: F11347-25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2014
• 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