MAUDE Adverse Event Report: THERAKOS THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Lot Number E121 - KIT

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

Patient Problems Fatigue (1849); Fever (1858); Headache (1880); Low Blood Pressure/ Hypotension (1914); Sepsis (2067)

Event Date 08/30/2016

Event Type  Injury  

Manufacturer Narrative

System was used for treatment.Kit lot e121 was reviewed.There were no non-conformances.This lot met all release requirements.The uvadex lot number was not provided.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 categories fever, fatigue, hypotension, sepsis, headache and shortness of breath and no trend was detected for either of these categories.This assessment is based on information available at the time of the investigation.This is reportable from the device perspective.Out of an abundance of caution this will be reported.Although the procedure was completed without incident and it is unlikely this is related to the ecp treatments; however, it cannot be ruled out as a contributory cause of the event.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.(b)(4).Device not returned.

Event Description

Physician reported that the night after patient's treatment on (b)(6), patient - who is an inpatient - was feeling unwell.He had a blood pressure drop and the physicians suspected sepsis.Physicians expressively stated they do not believe the event was related to ecp.This is based on the patient reporting fever from the day before the ecp treatment.Patient had one ecp treatment on (b)(6), two on (b)(6) and one on (b)(6).He was unwell the night between (b)(6) 2016, he recovered but decision was made to postpone that day's treatment to a later day.Patient reported he had 38.8 c fever and headache on (b)(6), the day before ecp treatment.The night between (b)(6): at 16h45 (b)(6) 2016, patient was reported to be tired and feeling slow, but fully conscious and clear in mind.Pain from contractions in skin and headache due to his underlying condition.At 20h (b)(6) 2016, patient reported that the last two days he had been feeling unwell with fever, headache, and some difficulties in breathing.Examination revealed decreased general condition.Patient was given antibiotics.Patient had a higher need for fluids during the night.At 4.00 h (b)(6) 2016, it was stated that almost 4l of fluids had been given during the last 12h and 5l o2.Blood pressure was now stable and fluid administration was stopped.

• 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: 5986514
• MDR Text Key: 55891439
• Report Number: 2523595-2016-00213
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: (01)10705030100009(11)150922
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/31/2016

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: 04/01/2018
• Device Lot Number: E121 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2016
• Initial Date FDA Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2016
• 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): Required Intervention
• Patient Age: 20 YR
• Patient Weight: 57