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

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

Patient Problem Test Result (2695)

Event Date 09/17/2014

Event Type  Injury  

Event Description

Patient is a child who has cgvhd following bone marrow transplant for scid.He has haemolysis, which the team thinks is due to early withdrawal of steroids.Despite rbc transfusion his hemoglobin drops.It is currently running around 6g/dl, with a hct in the low 20s.They have commenced retuximab and will rest him this week from ecp.He is given some return volume at the end of treatment to raise hb and avoid excessive donor exposures.(but fe is of course also very elevated).It was reported that they haven't had any problem with the actual ecp procedure, but are wondering if anyone else has any experienced with this king of situation and patient and if it's okay to continue.The customer asserts the that hemolysis is not connected to the ecp treatment and no extra transfusion support was needed following this treatment.Patient was reported to be in stable condition.Medical affairs department responded to the customer.No product was returned for investigation.

Manufacturer Narrative

No kit lot number was reported; therefore, no batch record review was performed.Trends were reviewed for complaint category, hemolysis and no trends were detected.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.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave.; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east; suite 140; bridgewater, NJ 08807
• MDR Report Key: 4171991
• MDR Text Key: 5157689
• Report Number: 2523595-2014-00264
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 09/17/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2014
• Initial Date FDA Received: 10/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 4 YR
• Patient Weight: 11