MAUDE Adverse Event Report: THERAKOS INC THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Lot Number C132 - KIT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Respiratory Failure (2484)

Event Date 02/15/2015

Event Type  Death  

Event Description

Received notification related to tc-v, on (b)(6) 2015 from (b)(4) study sponsor that patient (b)(6) had an adverse event.Event details are as follows: respiration failure on (b)(6) 2015, considered life threatening.As of (b)(6) 2015, patient had not recovered from event.(b)(6) 2015: icf was taken, cgvhd score/lung: 3 bo.(b)(6) 2015: tc-v started.(b)(6) 2015: ground-glass appearance, thickened wall, and partial consolidation were found in both superior lobe of the lung and s3 by ct.(b)(6) 2015: disturbance of consciousness in early morning by blood gas exam, co2 narcosis, she was treated with a ventilator, started antibiotics and steroid pulse therapy due to worsening lung gvhd and respiration failure.Methylprednisolone sodium succinate iv 500mg.Cravit drop infusion intravenous pack 500mg.Humilin r vial for steroid dm.She showed improvement on co2 narcosis and conscious level.(b)(6) 2015: effort respiration continuing.Judged to determinate the clinical trial.(b)(4).Since her lung inflammation was caused by infectivity as cghvd and steroid treatment, the reporter does not think there is relation between sae and ecp treatment.Information related to treatment is from treatment date of (b)(6) 2015.No product will be returned.

Manufacturer Narrative

A review of lot c132 was performed and there were no non-conformances for this lot.This lot met all release requirements.Trends were reviewed for events related to this complaint and there were no trend detected.The assessment is based on information available at the time of the investigation.The patient's respiratory failure was mos likely related to the patient's underlying condition; however, since the patient required medical intervention, this case is serious and was assessed as reportable.(b)(4).

Manufacturer Narrative

(b)(6) 2015: effort respiration continuing.Judged to terminate the clinical trial for patient.(b)(6) 2015: physician stated patient has recovered from infection.Patient is stable at this time.March 25, 2015: received information from (b)(6) hospital that patient (b)(6)expired on (b)(6) 2015.(b)(6) female with pulmonary gvhd and pneumonia died of cardiac arrest on (b)(6) 2015.The patient's last procedure was (b)(6) 2015.Patient was taken off ecp clinical trial on (b)(6) 2015.The death occurred one month and 4 days after the patient was taken off the clinical trial.Attending physician assessed this case as "the relation between death and the clinical trial is denied." uvadex was administered while the patient was on the trial, however this case has no relationship to uvadex, because there is no temporal relationship.This case has no relation to ecp procedure as the cause of the death is due to the patient's underlying condition.This case is serious, unrelated and reportable as a supplemental report.The patient was first hospitalized for respiratory failure due to the patient's underlying condition.Patient's condition worsened and passed away about 6 weeks after first hospitalization.There is no evidence of device malfunction.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS INC; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey avenue; buffalo NY 14211
• Manufacturer Contact: dianna inguanzo ; 10 north high street; suite 300; west chester, PA 19380
• MDR Report Key: 4584677
• MDR Text Key: 5481947
• Report Number: 2523595-2015-00052
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2015

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: 09/01/2016
• Device Lot Number: C132 - KIT
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2015
• Initial Date FDA Received: 03/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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): Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 30