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

Lot Number C735 - KIT

Device Problems Device Emits Odor (1425); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2014

Event Type  malfunction  

Event Description

Customer called to report lamp failure alarm during photoactivation and a burning smell.Customer explained that in the middle of photoactivation, they had a lamp failure alarm.Customer aborted the procedure and will return blood/products to the pt.Customer stated there is no smoke coming from the machine.Customer stated pt is alright.Customer stated no one has been injured from the smell from the instrument.Customer stated 30 mins were left to complete photoactivation.Customer was told that the attending physician should be informed of pt receiving untreated cells.Customer was informed that pt should be instructed to be fully protected from the sun.Service order: (b)(4) was dispatched.Product will not be returned.

Manufacturer Narrative

Service order (b)(4) was dispatched.Tech performed diagnostics and found a bad fsc board.A new fsc board was installed.Tech performed bowl optics and thermocouple calibration.The new board successfully completed system checkout procedure.At the time of the investigation, no trend was detected for complaint category lamp failure alarm or smell.There was no capa initiated for complaint category lamp failure alarm or smell.The product was not returned for further analysis; therefore, it could not be determined if this specific product met specifications.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continuous improvement process.No further action is required at this time.

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Type of Device: XTS
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 e; ste 140; bridgewater, NJ 08807
• MDR Report Key: 4152516
• MDR Text Key: 4927278
• Report Number: 2523595-2014-00270
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/11/2014

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: 06/01/2019
• Device Lot Number: C735 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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