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

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

Patient Problem Anemia (1706)

Event Date 01/01/2006

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.No kit lot number was provided; therefore, a batch record review could not be conducted.The uvadex lot number was not provided.However, a review of all uvadex lots manufactured since january 2013 was performed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for complaint category anemia.No trends were identified for anemia.From uvadex perspective, there is no evidence to suggest a causal relationship between the drug and the adverse event.This case is serious, unrelated and unexpected to uvadex.This is not reportable from a drug perspective.From a device perspective this event did not cause or contributed to a death or serious injury; and or the system did not cause or contributed to a death or serious injury nor malfunction in a way that would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.There is no device malfunction.Anemia is listed adverse event in the cellex om section 2-2 (treatment frequency exceeding labeling recommendations may result in anemia).It is unknown how many treatments were given to the patient.Eighteen out of twenty (18/20) patients received iron supplementation.This is considered medical intervention.This case is reportable as an mdr.This assessment is based on information available at the time of the investigation.No product was returned by the customer for investigation; therefore, it could not be determined if this specific product met specification.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continuous improvement process.(b)(4).

Event Description

An email was received on 8-december-2015 with a link from the (b)(6) in which iron deficiency anemia is associated with extracorporeal photophoresis the 951 iron deficiency anemia associated with extracorporeal photophoresis: a retrospective analysis regulation of iron metabolism program: oral and poster abstracts session: 102.Regulation of iron metabolism: poster i.(b)(6) convention center) alexis k kuhn, pharmd , julianna a merten, pharmd , gabriel t bartoo, pharmd , ross a dierkhising, ms ,jeffrey l.Winters, md , mrinal m patnaik, mbbs , dennis a.Gastineau, md and jill adamski, md, phd department.(b)(6).Abstract: "since its emergence as a novel therapy for cutaneous t-cell lymphoma in 1987, extracorporeal photopheresis (ecp) has gained popularity in the fields of solid organ and stem cell transplantation (perotti et al transfus apher sci 2015).Though ecp is thought to be associated with few adverse effects, we have anecdotally noted that some patients treated with ecp develop iron deficiency anemia.Anemia has been reported in ecp literature at an incidence of anywhere from 0% to 24.5%, however, the etiology of the anemia has not been described (quaglino et al int j dermatol 2013, flowers et al blood 2008, jaksch et al j heart lung transpl 2012, dignan et al bone marrow transpl 2014).We performed a retrospective chart review to further investigate the magnitude of this potential adverse effect.".

• 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 19380
• MDR Report Key: 5323305
• MDR Text Key: 34253645
• Report Number: 2523595-2015-00314
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: 10705030100009
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2015

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: Other Health Care Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2015
• Initial Date FDA Received: 12/23/2015
• 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