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

Lot Number D715-KIT

Device Problems Air Leak (1008); Fluid/Blood Leak (1250); Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 08/20/2015

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot d715 was conducted.There were no nonconformances associated with this lot.The lot met release requirements.The uvadex lot number was not provided as it was not administered.However, a review of all uvadex lots manufactured since january 2013 was performed.No trends or noncoformances related to the complaint were noted.Trends were reviewed for complaint categories, flm leak, system error, and air detected alarm.No trends were detected for these complaint categories.A corrective and preventive action was initiated for complaint category, system error, and is now closed.This assessment is based on information available at the time of the investigation.The analysis of the kit and data key is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

The customer called to report fluid leaking from the fluid logic module (flm) during the first cycle of the treatment procedure.The customer stated a system error f212 occurred during prime.The customer cycled power to clear the alarm and completed the priming of the kit.The customer connected the patient and started the procedure.Then the customer noted air bubbles in the lines coming out of the flm.The customer stated that then he got air detected alarms, which could not be cleared.The customer opted to abort the treatment procedure with no return of blood/products to the patient.When unloading the flm from the instrument, the customer noted fluid on the outside of the flm.The customer stated that the patient was doing fine and that the patient would be started on a new procedure.The customer stated that service was not required at this time.The kit and data key were received for investigation.

Manufacturer Narrative

The data key and kit were returned for analysis.The data indicated a blood leak alarm (a sign that the customer was testing the leak sensor prior to the start of treatment) and a system error f212 occurred before prime.After clearing the system error, prime was completed.Blood collection started and several air detected alarms were seen.The treatment was aborted.The kit was pressure tested and a leak was found in the joint between the ac delivery line and its port on the flm.The root cause for the leak is, most likely, a manufacturing operator error during the tube bonding process.A corrective action was initiated which included retraining of the manufacturing operators who perform this task.In addition, a second corrective action was initiated to study the effects of differing solvent bond methods.(b)(4).

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Type of Device: XTS
• Manufacturer (Section D): THERAKOS, INC; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: dianna inguanzo ; 10 north high street; suite 300; west chester, PA 19380
• MDR Report Key: 5069477
• MDR Text Key: 26114481
• Report Number: 2523595-2015-00243
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100016
• UDI-Public: 10705030100016
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Report Date: 08/20/2015

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: Nurse
• Device Expiration Date: 04/01/2020
• Device Lot Number: D715-KIT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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: 77 YR
• Patient Weight: 50