MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

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

Patient Problems Congestive Heart Failure (1783); Itching Sensation (1943); Swelling (2091)

Event Date 11/10/2010

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.Since the device could not be ruled out as a possible contributing factor to this event, this case will be reported as a mdr out of an abundance of caution.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.The instrument's serial number was not provided; therefore, a device history review could not be conducted.Trends were reviewed for complaint categories, other adverse event: itching, swelling, and other adverse event: congestive heart failure.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: itching, swelling, and congestive heart failure (b)(4).

Event Description

The patient reported under the ambassador program that within fifteen minutes of getting off of the instrument, she still had issues with itching.The patient stated that she had a tough time sleeping because of the itching.The patient reported that her feet were beginning to swell and she had a hard time walking.The patient stated that she had congestive heart failure in 2011.The patient reported that she was hospitalized due to her congestive heart failure.The patient stated that she could not say for sure if the congestive heart failure was due to her treatment or due to her underlying condition, but the events did occur after a treatment.The patient's duration of treatment was from nov 2010 to may 2011 (5 months).No product was specified in the complaint.No product was returned for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC; bedminster NJ
• 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: 6856968
• MDR Text Key: 85744374
• Report Number: 2523595-2017-00169
• Device Sequence Number: 1
• Product Code: LNR
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/11/2017

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2017
• Initial Date FDA Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 67 YR