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

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Death (1802); Multiple Organ Failure (3261)

Event Date 10/03/2014

Event Type  Death  

Event Description

Event reported in a literature article: journal of pediatric hematology/oncology 2014;00:000-000.Accepted for publication 10/03/2014."safety and outcomes of extracorporeal photopheresis with the therakos cellex system for graft-versus-host-disease in pediatric patients." (b)(6) year old boy, one of four patients (all four with liver involvement) in a retrospective review of twelve pediatric patients that failed to respond to the treatment died of multi-organ failure, no steroid tapering.Hsct indication: mds, myelodysplastic syndrome.Donor: (b)(6), matched unrelated donor (b)(6).Stem cell: pbsc (peripheral blood stem cell).Onset of gvhd (wk): 1.Gvhd treatment (pre-ecp): csa (cyclosporine), tacr (tacrolimus), mmf (mycophenolate mofetil), mp (methylprednisolone), atg (antithymocyte globulin).Internal between onset of gvhd and ecp (wk): 2.Gvhd type: acute (biopsy proven).Affected organs (stage in agvhd, score in cgvhd): skin (4), gis gastrointestinal (3), liver (2).Degree of gvhd: grade 4 acute gvhd.Improvement: acute grade 4 to 3.Ecp procedures: 8.Gvhd treatment during ecp: tacr, mmf, mp.Beginning of improvement (if any), (number of procedures): 4.Survival: expired.Current status: died of multi-organ failure, no steroid tapering.Date of death was not reported.

Manufacturer Narrative

No lot number was reported, therefore, no batch record review was performed.There were no trends detected for complaint categories, death or multi-organ failure.(b)(6) year old male with grade 4 acute gvhd of mds died of multi-organ failure.Pt only had 8 ecp treatments.This case is serious and not related to ecp therapy.Therakos is reporting this out of an abundance of caution.Kit unique identifier (udi) #:.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: 440 us route, 22 e; ste 140; bridgewater, NJ 08807
• MDR Report Key: 4326980
• MDR Text Key: 5245762
• Report Number: 2523595-2014-00321
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: Physician
• Type of Report: Initial
• Report Date: 12/08/2014

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: 12/08/2014
• Initial Date FDA Received: 12/11/2014
• 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): Death
• Patient Age: 12 YR
• Patient Weight: 30