MAUDE Adverse Event Report: THERAKOS, INC XTS PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

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

Patient Problem No Information (3190)

Event Date 01/18/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction of the centrifuge bowl leak/break , and this reportable malfunction is only associated with the kit.A batch record review of kit lot e724 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot e724 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories, leak centrifuge alarm and centrifuge bowl leak/break.No trends were detected for these complaint categories.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.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.(b)(4).Device not returned to manufacturer.

Event Description

The customer called to report a leak centrifuge alarm that occurred during the first cycle of a treatment.The customer stated that after the centrifuge bowl had stopped and with the instrument in a paused state, they opened the centrifuge cover in order to inspect the centrifuge chamber.The customer reported that they did not see any leak upon their initial inspection of the centrifuge chamber.The customer stated that they decided to abort the treatment with no blood/product returned to the patient.The customer reported that the patient was in stable condition.The customer stated that they couldn't clear the leak centrifuge alarm.The customer reported that they had powered the instrument off, cleaned the centrifuge chamber, and powered the instrument back on again.However, the customer stated that the leak centrifuge alarm continued to occur.The customer reported that they had cleaned all the way down to the bottom of the centrifuge chamber and they believed that the leak may have gone further down.The customer stated that it was only after uninstalling the kit and removing the centrifuge bowl from the centrifuge chamber, that they were finally able to find the location of the leak.The customer reported that they were then able to clean up all of the leak which cleared the leak centrifuge alarm.The customer stated that they were able to install a new kit, prime it, and successfully complete a procedure without any issues.The customer also reported that they were able to perform a second procedure with this instrument with no issues as well.The customer stated that they did not require service.The kit was not returned for investigation.

• Brand Name: XTS PHOTOPHERESIS SYSTEM
• Type of Device: XTS PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC; hampton NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; po box 9001; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 6338177
• MDR Text Key: 67959966
• Report Number: 2523595-2017-00038
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200027
• UDI-Public: (01)20705030200027(10)E724(17)210601
• 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
• Type of Report: Initial
• Report Date: 02/16/2017

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: 06/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: XT125
• Device Lot Number: E724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2017
• Initial Date FDA Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2016
• 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: 69 YR
• Patient Weight: 54