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

Lot Number C766 - KIT

Device Problems Fogging (1253); Device Displays Incorrect Message (2591)

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

Event Date 03/31/2015

Event Type  malfunction  

Event Description

Customer called and reported centrifuge leak alarm in 3rd cycle.Customer had system error se f535 message two times during treatment.After restart, a system error f183: centrifuge speed too slow message occurred.Css advised to check the centrifuge bowl and to verify the centrifuge cover was firmly closed.During 3rd cycle, centrifuge leak alarm occurred.Customer checked the centrifuge and found the glass of the centrifuge cover fogged with fluid.Css advised to check the bowl and in case of a leak to abort the treatment.Customer found a leak at the rotation seal of the bowl.Customer decided to abort the treatment and not to return the volume to the patient.Patient was reported to be in stable condition.Customer will not return product for investigation.

Manufacturer Narrative

A review of lot c766 was performed and there were no non-conformances.This lot met all release requirements.Trends were reviewed for all complaint categories and no trend was detected for centrifuge bowl leak/break, system error or system error f183: centrifuge speed too slow.No corrective and preventive actions were initiated for either centrifuge bowl leak/break nor for system error f183: centrifuge speed too slow.A corrective and preventive action was initiated for system error and is now closed.The assessment is based on information available at the time of the investigation.No product was returned by the customer for investigation.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continuous improvement process.(b)(4).

• 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 baily ave.; buffalo NY 14211
• Manufacturer Contact: dianna inguanzo ; 10 north high street; suite 300; west chester, PA 19380
• MDR Report Key: 4673963
• MDR Text Key: 18933734
• Report Number: 2523595-2015-00099
• Device Sequence Number: 1
• Product Code: LNR
• 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,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/31/2015

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: 12/01/2019
• Device Lot Number: C766 - KIT
• Other Device ID Number: 10705030100016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2015
• Initial Date FDA Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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: 59 YR
• Patient Weight: 60