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

Device Problem Device Contamination with Body Fluid (2317)

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

Event Date 11/24/2014

Event Type  malfunction  

Event Description

Therakos field engineer found dried blood in the photoactivation chamber and in the machine during service.Field engineer sent photos.No operator was onsite to ask about it.No related complaint was found in the machine history.Css called the customer on 25 november to follow up.The customer had no idea when the blood leak occurred.She is the main user of the machine.Customer stated that she cleans the machine after the treatments and once a week on friday a deep clean.She stated that she changed the light assembly but never found rest of blood in the machine.There was no service order generated.Photos were sent for investigation.

Manufacturer Narrative

No lot number was reported; no batch record review was performed.Trends were reviewed for complaint category, photoactivation module leak, and no trend was detected.No capa has been initiated for photoactivation module leak.The assessment is based on info available at the time of the investigation.Eval of the photographs is still in progress at the time of this report.A supplemental report will be filed when this eval is complete.(b)(4).

• Brand Name: THERAKOS XTS PHOTOPHERESIS 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; ste 140; bridgewater, NJ 08807
• MDR Report Key: 4361490
• MDR Text Key: 5289890
• Report Number: 2523595-2014-00316
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P680003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/24/2014

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
• Other Device ID Number: 10705030100016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2014
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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