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

Lot Number D362 - KIT

Device Problems Occlusion Within Device (1423); Device Displays Incorrect Message (2591)

Patient Problem Thrombus (2101)

Event Date 02/19/2016

Event Type  malfunction  

Manufacturer Narrative

This system was used for treatment.(b)(4) was reviewed.There were no non-conformances.This lot met all release requirements.The uvadex lot number was not provided as it was not administered.However, a review of all uvadex lots manufactured since january 2013 was performed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for complaint category clot observed or alarm #17: return pressure.This assessment is based on information available at the time of the investigation.No product was returned by the customer for investigation; therefore, it could not be determined if this specific product met specification.However, the most likely cause for this event is that the customer did not properly spike the anticoagulant and saline bags.The anticoagulant tubing was connected to the saline bag and the saline tubing was connected to the anticoagulant bag.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).

Event Description

Customer called to report multiple return pressure alarms at approximately 1300ml whole blood processed, customer stated the patient has a vortex port and the alarm will not clear.Customer stated they disconnected the return line from the patient and were not able to perform a saline bolus to waste due to the return pressure alarms, css advised the customer to strip the return line to waste to see if there are any aggregates or clots, customer confirmed there was a clot in the return line, customer then stated the anticoagulant bag and saline bag were not properly spiked, they were switched.Css advised the customer abort the procedure, customer confirmed the treatment was aborted and the patient was disconnected.Css called the customer back on (b)(6), customer stated the patient was stable, a post-cbc had been drawn, no medical intervention was required, the patient had edema prior to ecp therefore no fluids will be given to the patient.Customer stated the patient's vortex port is being treated with tpa.No product was returned for investigation.

• 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: 5506160
• MDR Text Key: 40796334
• Report Number: 2523595-2016-00056
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: 10705030100009
• 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: 02/19/2016

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: 10/01/2017
• Device Lot Number: D362 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2016
• Initial Date FDA Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2017
• 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