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

Lot Number C909-KIT

Device Problems Fitting Problem (2183); Device Displays Incorrect Message (2591)

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

Event Date 08/18/2015

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot c909 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 nonconformances related to the complaint were noted.Trends were reviewed for complaint categories, disposable failure alarm, leak centrifuge alarm, system error f182: centrifuge on when should be off, system error f281: 9 volt battery failure, and centrifuge bowl leak/break.No trends were detected for these complaint categories.A corrective and preventive action was initiated for complaint category, disposable failure alarm, and is now closed.(b)(4), feedback: the service technician replaced the bowl collar and successfully performed the system checkout procedure.No further action required.Product return analysis feedback: photos were returned for analysis.A review of the photos indicated that the top of the centrifuge bowl was not centered during installation in the instrument, relative to the covers and the metal centrifuge bowl collar was missing from one of the centrifuge covers.In the photos, black streaks can be seen on the top of the pink ring in the bowl seal and a blood leak is visible outside of the outlet bowl connector.No dried blood can be seen on the top of the bowl.The combination of the leak alarm and the need for extra torque (as the seal could not be easily rotated), is an indication that the bowl seal had lifted.The debris/ black streaks on the pink ring of the bowl seal indicated that fluid had leaked past the seal.This is, most likely, the root cause of the centrifuge leak alarm.There was also an observed leak between the bowl connector and the bowl outlet.This type of leak would not normally trigger a centrifuge leak alarm as the connector is above the centrifuge cover.However, given that the cover of the customer's instrument was missing a component and a portion of the chamber was exposed, it is unknown if a leak at this site triggered this alarm.Based on the photo analysis the root cause for the blood leak could not be determined.A device history review of the lot found no related nonconformances.This lot passed all lot release testing.(b)(4).Device not returned to manufacturer.

Event Description

The customer called to report a disposable failure alarm in prime.The customer performed troubleshooting according to the operator's manual, and was able to continue with the prime.During the last cycle, a leak centrifuge alarm occurred.The customer checked the centrifuge but found no fluid.After restarting the treatment, a system error f182: centrifuge on when should be off occurred.The customer powered off the machine.The customer released the bowl and reinstalled the bowl.The customer checked the bowl and found that the rotation seal could not be easily moved.The customer stated that the bowl's square top did not fit correctly into the centrifuge cover.When the customer restarted the machine, the fuse at the power outlet was switched off.The customer heard a continuous alarm at the restart off the machine.After the customer had switched on the fuse and restarted the machine, a system error f281: 9 volt battery failure occurred.The customer was advised to abort the treatment and return the volume by manual return.The patient was reported to be in stable condition.(b)(4), was dispatched on (b)(6), 2015.Photos have been received for evaluation.

• 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: 5078990
• MDR Text Key: 26501209
• Report Number: 2523595-2015-00239
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100016
• UDI-Public: 10705030100016
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Report Date: 08/18/2015

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: 11/01/2019
• Device Lot Number: C909-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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: 45 YR
• Patient Weight: 85