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

Lot Number C751

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

Patient Problems Fainting (1847); Low Blood Pressure/ Hypotension (1914); Nausea (1970)

Event Date 02/05/2015

Event Type  Injury  

Event Description

Sales manager forwarded information from the nurse: all was going well until the fifth cycle.Patient was drinking some warm soup and the said she felt not well.The patient reported nausea and then fainted.Hypotension.No pulse measurable.Bp 60/40.Actions taken: trendelenburg position.1000ml nacl 0.9% infusion, no transfusion.Small blood count.Continued monitoring ecg - pulse - saturation - bp paspertin 50mg (for nausea).After 10 minutes the patient recovered, treatment was continued and could be completed.Patient was well afterwards, parameters were stable.She was currently in another ecp procedure, all going well.No product was returned.Patient was already hospitalized (pneumology), independent from ecp, no prolongation due to this event.

Manufacturer Narrative

A review of lot c751 was performed and there were no nonconformances associated with this lot.This lot met release requirements.Trends were reviewed for complaint categories, fainting, hypotension, nausea, and dizziness, and no trends were detected.There was no capa initiated.This assessment is based on information available at the time of this report.No product was returned for evaluation; therefore, it could not be determined if this specific product met specifications.Based on internal medical assessment, (b)(6), during treatment not feeling well, nausea, then fainted.Administered 1000 ml nacl and parpertin for nausea.Patient recuperated and treatment resumed.Case is being reported due to medical intervention.(b)(4).

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Type of Device: XTS
• Manufacturer (Section D): THERAKOS INC.; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave.; buffalo NY 14211
• Manufacturer Contact: 10 north high street; suite 300; west chester, PA 19380
• MDR Report Key: 4558877
• MDR Text Key: 5560768
• Report Number: 2523595-2015-00049
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/06/2015

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: 09/01/2019
• Device Lot Number: C751
• Other Device ID Number: 10705030100016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2015
• Initial Date FDA Received: 02/27/2015
• 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): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 72