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

Lot Number C903

Device Problems Crack (1135); Leak/Splash (1354); Device Contamination with Body Fluid (2317); Device Displays Incorrect Message (2591); Noise, Audible (3273)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/18/2014

Event Type  malfunction  

Event Description

Customer reported a treatment was a few minutes into cycle one when a loud crack was heard and a blood leak alarm occurred, with a blood leak visible in the centrifuge.Customer stated the patient was stable.Customer stated the treatment was aborted at that time, the blood in the kit was not returned to the patient and no follow-up fluids were given to the patient.Customer reported the centrifuge drain bag was about one-quarter full of blood.Customer stated the bowl had already been removed from the centrifuge, and no bowl damage was visible.Service order (b)(4) was dispatched.Photos were sent for investigation.

Manufacturer Narrative

A review of lot c903 was performed and there were no nonconformances associated with this lot.This lot met release requirements.Trends were reviewed for complaint category, centrifuge bowl leak/break, and no trend was detected.Manufacturer (b)(4)has been initiated to investigate centrifuge bowl leak/breaks.Service order (b)(4) completed: service engineer discovered that blood leak had completely contaminated centrifuge and vacuum pump.Replaced centrifuge and pump after cleaning system.Calibrated bowl optics after replacement.Performed system checkout to confirm operation.No further action required.The assessment is based on information available at the time of the investigation.Evaluation of the photographs 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: 4339974
• MDR Text Key: 5201743
• Report Number: 2523595-2014-00309
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P680003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 05/01/2019
• Device Lot Number: C903
• Other Device ID Number: 10705030100016
• Was Device Available for Evaluation?: No
• 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?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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: 58 YR
• Patient Weight: 77