MAUDE Adverse Event Report: THERAKOS, INC. THERAKOS CELLEX SYSTEM

Lot Number C120-KIT

Device Problems Break (1069); Smoking (1585); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/26/2014

Event Type  malfunction  

Event Description

Customer reported white smoke coming out of the photoactivation door at the end of photoactivation.Lamp life left: 73.4 hrs.No alarms occurred.Treatment was successfully completed.Customer reported that when the event occurred they could hear a "smashing noise" and then there was white smoke coming out of the instrument.The nurses were worried the lamps were not functional, clinical services specialist (css) informed that if the lamps were broken there would be an alarm and they would not be able to proceed.Css advised the customer to monitor the machine in the following days and call back in case of problems.The next day, the customer reported that the machine was working normally, no alarms occurred.The pt was reported to be fine.There was no hemolysis and no blood leak.Smartcard data was retrieved on (b)(4) 2014.There was no service order generated.

Manufacturer Narrative

A review of lot c120 was conducted and there were no non-conformances associated with this lot.This lot met release requirements.Trends were reviewed for complaint category, smoke-direct/indirect, and no trends were detected.There was no capa for this complaint category.The assessment is based on info available at the time of the investigation.Analysis of the smart card data is still in progress at the time of this report, therefore final investigation findings are still pending.(b)(4).

• Brand Name: THERAKOS CELLEX SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 e; ste 140; bridgewater, NJ 08807
• MDR Report Key: 4202564
• MDR Text Key: 4981586
• Report Number: 2523595-2014-00239
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P680003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/26/2014

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: Health Professional
• Device Expiration Date: 05/01/2016
• Device Lot Number: C120-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2014
• Initial Date FDA Received: 09/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1