MAUDE Adverse Event Report: THERAKOS THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Lot Number E329 - KIT

Device Problem Missing Value Reason (3192)

Patient Problems Chest Pain (1776); Nausea (1970); Skin Irritation (2076); Vomiting (2144); Patient Problem/Medical Problem (2688)

Event Date 08/17/2016

Event Type  Injury  

Manufacturer Narrative

System was used for treatment.Kit lot e329 was reviewed.There were no non-conformances.This lot met all release requirements.Uvadex lot # ae6139 was reviewed.No trends related to the complaint were noted.Trends were reviewed for complaint categories vomiting, nausea, hear rate increased, skin irritation, and chest pain and no trend was detected for these categories.This assessment is based on information available at the time of the investigation.Customer stated the extracorporeal photopheresis (ecp) procedure was completed on a (b)(6) male patient with a diagnosis of acute skin graft vs.Host.This was the patient's first treatment procedure.When the patient lines were clamped and the customer was disconnecting the patient, the patient complained of nausea, and then vomited.Patient complained of itching, chest pain, and had puffy eyes and was tachycardic and redness of the skin.Customer stated they administered 25 ml iv promethazine.Rapid response was called but they did not administer any other medication to the patient.Patient was then transported to emergency room and then discharged later on the same day.Since we are unable to rule out the procedure as a contributing event, we are reporting this.There was no reported device malfunction.No product was returned by the customer for investigation; therefore, it could not be determined if this specific product met specification.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.(b)(4).

Event Description

Customer called to report adverse event after completion of treatment procedure.Event took place on (b)(6) 2016, customer reported event to therakos on (b)(4) 2016.Customer stated all uvadex treated cells and all remaining blood/products were returned to patient, all lines were clamped, customer went to disconnect patient, when patient complained of nausea, and then vomited.Patient complained of itching, chest pain, and had puffy eyes and was tachycardic and redness of skin.Customer stated they administered 25 ml iv promethazine.Rapid response was called, they did not administer any other medication to the patient.Patient was then transported to er, patient was later discharged on the same day.Customer stated patient will return on (b)(6) 2016 for second treatment.This was patient's first treatment procedure.Customer will not return product for investigation.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS; hampton NJ 08827
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street, suite 30; west chester PA 19380
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 5956551
• MDR Text Key: 54930785
• Report Number: 2523595-2016-00198
• Device Sequence Number: 1
• Product Code: LNR
• 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: 08/18/2016

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?: No
• Device Operator: Nurse
• Device Expiration Date: 06/01/2018
• Device Lot Number: E329 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• 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: 23 YR
• Patient Weight: 73