MAUDE Adverse Event Report: THERAKOS THERAKOS CELLEX PHOTOPHERESIS SYSTEM

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Patient Problem/Medical Problem (2688)

Event Date 05/29/2015

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.No kit lot number was provided; therefore, batch record review could not be conducted.No uvadex lot number was provided.However, a review of all uvadex lots manufactured since january 2013 was performed.No trends related to the complaint were noted.Trends were reviewed for complaint category, other adverse event (hemodynamic instability).No trends were identified.The system was used for treatment of disease.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 contribute to a death or serious injury; and /or the system did not cause or contribute 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 was no device malfunction.The patient ae (hemodynamic instability) occurred after treatment and the hemodynamic instability was treated while the patient was in the hospital.The customer elected to perform the treatment without blood prime as was advised by their therakos trainer.This case is reportable as an mdr as there was medical intervention provided due to the hemodynamic instability.This assessment is based on information available at the time of this report.No product was returned for evaluation; therefore, it could mot be determined if this specific product met specifications.(b)(4).Device not returned.

Event Description

Physician mentioned that there had been a treatment where the therakos trainer advised the use of blood prime for a patient.However, the clinician in charge ordered the treatment to be performed without the blood prime and complications arose (hemodynamic instability).The customer stated that this reaction was not uncommon for the patient to experience due to the patient's current medical condition and they deemed at the time that this was not a reaction that was related to performing photopheresis.The therakos trainer was not present when the treatment was performed.The trainer was contacted by multiple people at the account and a therakos physician to discuss extracorporeal volume and the implications associated with utilizing/ not utilizing the blood prime procedure.After these discussions, the customer had the information necessary to make an informed decision regarding treating/ not treating the patient with the ultimate decision being that of the patient's physician.Customer (physician) provided the updated summary to the therakos trainer via clinical services on (b)(6) 2015: the physician stated that a therakos trainer had been at their facility earlier in the week for the anticipated ecp treatment of this patient.However, it could not be done at the hospital because the cellex instrument was out of service.The trainer then left the hospital.Therakos did not encourage moving instruments from one location to another, the directing physician elected to transport the patient to the outpatient area for treatment on another cellex instrument.The treatment was performed by a nurse who was not certified and had limited experience (<2 cellex ecp treatments).The patient was then transported from the outpatient area back to the hospital and experienced complications due to hemodynamic instability over the next few days.The physician stated that she did not think that the patient's hospital stay was extended due to ecp, but there were more challenges than should have been required.After the patient's hemodynamic stability improved, they continued to treat using blood prime until the patient's weight and hematocrit increased.The patient is now able to receive treatment without the need of blood prime.The physician reported that the patient is responding well to treatment.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS; 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: 5347786
• MDR Text Key: 35169550
• Report Number: 2523595-2016-00001
• 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: health professional,user faci
• 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: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2015
• Initial Date FDA Received: 01/06/2016
• 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