MAUDE Adverse Event Report: THERAKOS, INC THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Lot Number D144 - KIT

Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591)

Patient Problem Unspecified Infection (1930)

Event Date 01/20/2016

Event Type  malfunction  

Manufacturer Narrative

System was used for treatment.Kit lot d144 was reviewed.There were no non-conformances.This lot met all release requirements.The (b)(4) lot number was not provided as it was not administered.However, a review of all (b)(4) lots manufactured since january 2013 was performed.No trends or noncoformances related to the complaint were noted.Trends were reviewed for all complaint categories and no trend was detected for drive tube leak/break, alarm #17: return pressure, alarm #18: system pressure or central line infection.However, corrective and preventive actions have already been initiated for drive tube leak/breaks.This assessment is based on the information available at the time of the investigation.The photo analysis is still in progress at the time of this report.A supplemental report will be filed once investigation is complete.(b)(4).

Event Description

Customer called to report blood leak during buffy coat collection.Dual needle mode.30ml/min collect rate.Procedure time was approximately 70 minutes.Acda.Apheresis catheter for access.Customer received a return pressure alarm followed by a system pressure alarm.Customer opened the centrifuge and noted a horizontal cut at the base of the drive tube.Treatment was aborted.Customer states they were able to clean the centrifuge and is not requesting service at this time.On 8-february 2016, therakos received correspondence from customer where they reported change in status of patient.As per customer correspondence, patient was admitted to hospital on (b)(6) 2016 with infected line, possible systemic infection.Line was removed and patient was undergoing treatment.Photophoresis treatments were put on hold.According to the customer, the patient received 10 days of iv antibiotics and 10 days of oral antibiotics.Patient is infection free at this time.The customer has agreed to return pictures for investigation.The kit has been disposed of.

Manufacturer Narrative

A photo analysis was conducted.Review of the customer supplied photographs confirmed the reported blood leak from the base of the drive tube, just above the lower clamp.There are no similar product returns for kit lot d144.The analysis determined the root cause of the reported leak is most likely that the lower bearing stop delaminated allowing the drive tube to twist against the lower drive tube clamp.Corrective and preventive action has already been initiated to address drive tube surface treatment improvement prior to over molding of the bearing stop.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC; hampton NJ 08827
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave; buffalo NY 14211
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 5441911
• MDR Text Key: 38997387
• Report Number: 2523595-2016-00027
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: 10705030100009
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 10/01/2017
• Device Lot Number: D144 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2016
• Initial Date FDA Received: 02/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• 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: 30 YR
• Patient Weight: 103