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

Lot Number C737

Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591); Moisture or Humidity Problem (2986); Noise, Audible (3273)

Patient Problem Dizziness (2194)

Event Date 11/18/2014

Event Type  malfunction  

Event Description

Customer reported a treatment was in cycle six collect phase when an intermittent noise was heard to be coming from the top of the centrifuge bowl.Customer reported a blood leak alarm then occurred, with condensation appearing under the centrifuge lid.Customer stated the treatment was aborted at that time and the bowl was immediately clamped off.Customer stated she consulted with the physician assistant, and then completed a manual return of most of the blood in the kit to the patient, except for the volume in the bowl and in the photoactivation module.Customer estimated about 150 ml of blood was not returned to the patient.Customer stated when the inside of the centrifuge was wiped with gauze, only one drop of blood was observed on the gauze.Customer reported the centrifuge drain bag was empty.Customer reported patient is stable.Customer stated patient reported feeling a little light-headed immediately after the leak occurred, but the patient felt normal within ten minutes.Customer indicated no field service is needed.No service order was generated.Kit was returned for investigation.

Manufacturer Narrative

A review of lot c737 was conducted and there were no nonconformances related to this type of event.This lot met release requirements.Trends were reviewed for complaint categories, centrifuge bowl leak/break and feeling abnormal.No trends were detected for either complaint category.No capas were initiated.The negative fluid shift of ecp therapy is the probable cause of feeling lightheaded.There was no medical intervention.This case is reportable due to the blood leak not the ae.The assessment is based on information available at the time of the investigation.Evaluation of the returned kit is still in progress at the time of this report.A supplemental report will be filed when this evaluation is complete.(b)(4).

• 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 east; suite 140; bridgewater, NJ 08807
• MDR Report Key: 4339986
• MDR Text Key: 5178910
• Report Number: 2523595-2014-00308
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P680003
• 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: 11/18/2014

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: C737
• Other Device ID Number: 10705030100016
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/26/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2014
• Initial Date FDA Received: 12/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 61 YR
• Patient Weight: 77