MAUDE Adverse Event Report: THERAKOS XTS PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Disconnection (1171); Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction tubing leak.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.No kit lot was provided; therefore, no batch record review could be conducted.Trends were reviewed for complaint category, tubing leak.No trends were detected for this complaint category.The assessment is based on the information available at the time of 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.Investigation complete.(b)(4).Device not returned.

Event Description

Customer called to report the tubing disconnected from the centrifuge bowl when attempting to empty residual fluid from the centrifuge bowl.The tubing disconnected and leaked after the procedure was completed.All blood products from the treatment and return bags were reinfused to the patient.The customer was unable to return the residual volume.Customer stated there were no alarms during the procedure.Customer will not be returning product for investigation.

• Brand Name: XTS PHOTOPHERESIS SYSTEM
• Type of Device: XTS PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; hampton NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 53 frontage road; p.o. box 9001; hampton, NJ 08827
• MDR Report Key: 6676467
• MDR Text Key: 78983134
• Report Number: 2523595-2017-00135
• Device Sequence Number: 1
• Product Code: LNR
• 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: 06/29/2017

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 Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT PROVIDED
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2017
• Initial Date FDA Received: 06/29/2017
• 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