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

Lot Number C356

Device Problem Insufficient Information (3190)

Patient Problem Hematuria (2558)

Event Date 01/14/2015

Event Type  Injury  

Event Description

Therakos clinical educator reported the following: md at customer site reported patient with positive hematuria following day 2 of ecp therapy.Day 1 of ecp, (b)(6) 2015, dual port was packed with tpa and removed on day 2 of ecp, (b)(6) 2015.After ecp was completed on (b)(6) 2015, patient voided and noticed his urine to be reddish/brown.Customer also took a sample of the fluid from the patient's return line from the cellex procedural kit that was used to treat the patient on (b)(6) 2015 and reported no hemolysis found in the kit.Customer stated the patient tested (b)(6) for uti, (b)(6) for bilirubin, increase in wbc.Md stated that patient "may have kidney stones".Later the same night, (b)(6) 20015, patient had shakes and chills, went back to the doctor who prescribed the patient 7 day antibiotic treatment.

Manufacturer Narrative

A review of lot c356 was performed and there were no nonconformances associated with this lot.This lot met release requirements.A review of complaint categories shows no trends for haematuria.No capa has been initiated for this complaint category.Based on the medical assessment, patient with ctcl- mycosis fungoides notices reddish/brown urine after his second ecp treatment.His urinalysis is negative for uti, bilirubin but positive for wbcs.Patient's md stated the patient "may have a kidney stone." patient later developed shakes and chills and was prescribed an antibiotic.Patient is stable and healthcare provider believes the haematuria is not related to ecp.Patient's underlying condition is probable cause of the haematuria but ecp cannot be ruled out.This case is serious and unlikely related to ecp.This assessment is based on information available at the time of investigation.No product was returned for investigation; therefore it could not be determined if the product met specifications based solely on information provided by the customer.Complaints are monitored through tracking and trending.Should a trend arise, further action will be taken.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave.; buffalo NJ 14211
• Manufacturer Contact: 440 us route 22 east, suite 140; bridgewater, NJ 08807
• MDR Report Key: 4493699
• MDR Text Key: 5328123
• Report Number: 2523595-2015-00025
• 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: 01/21/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2016
• Device Lot Number: C356
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2015
• Initial Date FDA Received: 02/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 77