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

Lot Number D302 - KIT

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Dizziness (2194)

Event Date 03/25/2015

Event Type  Injury  

Event Description

Customer called to inquire the amount of whole blood processed in order to collect a buffy coat, css explained that 500ml whole blood processed (wbp) and the optic sensor needs to detect the optimal interface in order for the buffy coat collection to be initiated manually.Customer explained that the patient's blood pressure dropped from 104/77 to 88/60 early in the treatment, the customer stated they gave a 250ml saline bolus and 250ml albumin transfusion to the patient before resuming with the ecp treatment.Customer stated the patient is feeling dizzy and they are currently at 445ml wbp.Css advised the customer to end the treatment, give all fluids back to the patient and if the patient feels better and the ordering physician approves, they can start over with a new kit.Customer understood css advise and explained they would ask the ordering physician to advise.Css called the customer back, the customer stated they decided to continue with the patient treatment and forced the buffy coat collection at 500ml wbp, during photoactivate they gave the patient another 90ml saline bolus due to the patient's blood pressure being 86/62.Customer explained that this patient is a lung transplant patient that experienced a pulmonary embolism after the transplant and had open heart surgery for the embolism, customer was not able to find the dates of transplant, pulmonary embolism, or heart surgery.Customer stated the heart surgery was "not too long ago" and that the patient has blood pressure readings that change frequently and are on the lower side, customer stated that the patient had blood pressure readings of 77/70 last week.Patient platelet count is 166,000.Patient reported as stable.Customer has declined to return the kit for further investigation.

Manufacturer Narrative

A review of lot d302 was performed and there were there were no non-conformances for this lot.This lot met all release requirements.Trends were reviewed for all complaint categories and no trends were detected for dizziness nor for hypotension.No corrective and preventive actions have been initiated for this complaint categories.The assessment is based on information available at the time of the investigation.(b)(4) male patient with gvhd lung developed hypotension and dizziness during treatment.Treatment was completed with no further issues.However, albumin and saline were given to the patient.Hypotension is a known adverse event of ecp treatment due to the fluid shift and an albumin transfusion is considered medical intervention.This case has been assessed as serious, related and reportable.Kit unique identifier (udi)#: (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 ave; buffalo NY 14211
• Manufacturer Contact: dianna inguanzo ; 10 north high street; suite 300; west chester, PA
• MDR Report Key: 4673830
• MDR Text Key: 21328645
• Report Number: 2523595-2015-00098
• 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 Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/25/2015

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: Nurse
• Device Expiration Date: 01/01/2017
• Device Lot Number: D302 - KIT
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2015
• Initial Date FDA Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 63 YR