MAUDE Adverse Event Report: THERAKOS, INC. THERAKOS CELLEX PHOTOPHERESIS SYSEM

Lot Number C128/413

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Pleural Effusion (2010)

Event Date 12/18/2014

Event Type  Injury  

Event Description

Pt began ecp treatment (b)(6) 2014, the pt received ecp treatment #27 without specific ae.The info on kit, treatment, and instrument are from the pt treatment on 12/10/2014.The clinical coordinator reported to a monitor that the pt visited a hosp in (b)(6) with dyspnea on (b)(6) 2014 and was admitted same day.Bp: 166/107mmhg, heart rate: 131/min, breathing rate: 51 times/min, spo2: 96%, bt 35.8c.Md diagnosed heart failure by chest x-ray: heart enlargement, bilateral pleural effusions.Protocol r injection, diuretic (furosemide).Pt had cardiac echo on (b)(6) 2014 to check the cardiac function, function was good and pleural effusion was decreased.(b)(6) 2015: chest x-ray revealed the effusion had cleared up.

Manufacturer Narrative

A review of lot c128 was performed and there were no non-conformances associated with this lot.This lot met release requirements.A review of complaint categories show no trends for shortness of breath.No capa has been initiated for this complaint category.Trends were reviewed for this complaint category shortness of breath.There were not trends for this complaint category.No capa was initiated for this complaint category.Pt's underlying condition is the probable trigger for the pleural effusion that caused the shortness of breath.This case is serious and unrelated to ecp.This assessment is based on info available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the info provided by the customer.Complaints are monitored through tracking and trending.Kit unique device: (b)(4).Late report is being addressed through (b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MED PRODUCTS; 2201 baily ave; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east; ste 140; bridgewater, NJ 08807
• MDR Report Key: 4454347
• MDR Text Key: 5421657
• Report Number: 2523595-2015-00017
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/21/2014

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: 08/01/2016
• Device Lot Number: C128/413
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2014
• Initial Date FDA Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 67