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

Lot Number C702-KIT

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 07/09/2014

Event Type  malfunction  

Event Description

Customer called to report fluid leaking from photoactivation plate.Customer stated it was noted just as photoactivation was near completion.Css asked if patient was okay, customer stated patient was fine.Css asked if anyone was splashed with biohazard fluid due to the leak, customer stated no one was splashed as the leak was contained within the photoactivation chamber.Css asked where the fluid was leaking from on the plate.Customer stated it was leaking from a crack in the plate.Css asked customer to return kit for investigation.Customer declined, stated it was too messy to return.Css asked customer to send pictures.Customer declined.

Manufacturer Narrative

A review of lot c702 was conducted.There were no nonconformances associated with this type of failure or this lot.The lot met release requirements.Trends have been reviewed for this complaint category and no trends have been detected for photoactivation module leak.The assessment is based on information available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.

• Brand Name: THERAKOS XTS SYSTEM
• 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 east; suite 140; bridgewater, NJ 08807
• MDR Report Key: 4088269
• MDR Text Key: 4745550
• Report Number: 2523595-2014-00200
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/09/2014

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: 01/01/2019
• Device Lot Number: C702-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2014
• Initial Date FDA Received: 08/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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
• Patient Age: 52 YR
• Patient Weight: 95