MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

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

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Nausea (1970); Rash (2033); Swelling (2091); Dizziness (2194)

Event Date 11/15/2017

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the medical intervention of the adrenalin and hydrocortisone that was given to the patient and also due to the patient being hospitalized.Since this event is associated with the treatment, this mdr will be against the instrument.From the device perspective, there was no known device malfunction and no instrument issue was alleged by the customer.No service was requested by the customer for this adverse event.No product was returned therefore, a device service history review was performed.The customer has their own biomed who performs the service on this instrument.Trends were reviewed for complaint categories, allergic reaction, shortness of breath, dizziness, swelling, nausea, and rash.No trends were detected for these complaint categories.The assessment is based on information available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Adverse event terms: hypersensitivity, dyspnea, dizziness, swelling, nausea, and rash.(b)(4).

Event Description

The customer called to report that a patient experienced a possible anaphylactic reaction during a treatment procedure.The customer stated that towards the end of the treatment procedure, the patient experienced dyspnea, dizziness, facial swelling, nausea and a rash on both his face and arms.The customer reported that at this time all of the drug treated cells had been reinfused back to the patient.The customer stated that the treatment was then ended with no blood returned to the patient.The customer reported that the patient was administered 300 ug of adrenalin as well as an iv of 200 mg hydrocortisone.The customer stated that the medications produced a rapid resolution of the event and the patient's symptoms resolved.The customer reported that the patient was admitted overnight and discharged the next day in stable condition.The customer stated that they were unclear as to the cause for the patient's reaction, but suspected it could have been due to the iron infusion that was given to the patient before the treatment procedure.No product was returned for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; 1425 us route 206; bedminster NJ 07921
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 7101420
• MDR Text Key: 94358820
• Report Number: 2523595-2017-00229
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/08/2017

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: Nurse
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CELLEX
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2017
• Initial Date FDA Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 43 YR