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

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

Patient Problem 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 october 3, 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 and died of mucormycosis, evolved into mild chronic gvhd (skin).Hsct indication: fa, fanconi anemia donor: (b)(6), matched unrelated donor (b)(6).Stem cell: bm, bone marrow.Onset of gvhd (wk): 8.Gvhd treatment (pre-ecp): csa (cyclosporine), tacr (tacrolimus), mmf (mycophenolate mofetil), mp (methylprednisolone), sirolimus interval between onset of gvhd and ecp (wk): 13.Gvhd type: acute (biopsy proven).Affected organs (stage in agvhd, score in cgvhd): skin (2) degree of gvhd: grade 1 acute gvhd.Improvement: acute: grade 1 to 0.Ecp procedures: 6.Gvhd treatment during ecp: sirolimus.Beginning of improvement (if any) (number of procedures): 4.Survival: expired.Current status: died of mucormycosis, evolved into mild chronic gvhd (skin).The 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 1 acute gvhd of fanconi anemia died of mucormycosis; evolved into mild chronic gvhd.Patient only had 6 ecp treatments.This case is serious and not related to ecp therapy.Therakos is reporting this out of abundance of caution.Kit unique identifier (udi)#: (b)(4).

• 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: 4326997
• MDR Text Key: 5253629
• Report Number: 2523595-2014-00323
• 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
• Other Device ID Number: 10705030100009
• 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: 68