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

Lot Number REQUESTED NOT PROVIDED-KIT

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

Patient Problems Diarrhea (1811); Fever (1858); Vomiting (2144); Malaise (2359)

Event Date 06/21/2016

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.The kit lot number was not provided; therefore, a batch record review could not be performed.The (b)(4) lot number was not provided.However, a review of all (b)(4) lots manufactured since january 2013 was performed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for complaint categories, malaise, fever, vomiting and diarrhea.No trends were detected for these complaint categories.From a device perspective, there is no known device malfunction.However, out of an abundance of caution, this case will be reported as an mdr, since the patient was admitted to the hospital post treatment.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: malaise, fever, vomiting and diarrhea.(b)(4).Device not returned to manufacturer.

Event Description

The customer reported that a patient wasn't feeling well, had developed a fever and was vomiting after an extracorporeal photopheresis (ecp) treatment on (b)(6) 2016.The customer stated that the patient was taken in for observation and was now stable.The customer stated that this was the patient's fourth ecp treatment cycle.On june 23, 2016, the customer stated that the patient had to be admitted to the ward after the ecp treatment on (b)(6) 2016.The customer reported that the patient was on a diuretic but was not taking the diuretic during her ecp treatments, since the patient was considered to be dehydrated at her first ecp treatment.The customer reported that the patient called after the first day of her fourth ecp treatment cycle to report that she felt sick, had diarrhea, and a fever.The customer stated that the patient was admitted to the ward and isolated in case of a virus.The customer reported that the patient spent the night in the ward and then had her ecp treatment the next day after being cleared by the doctor.The kit was not returned for investigation.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC; hampton NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 5811079
• MDR Text Key: 50059242
• Report Number: 2523595-2016-00166
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: (01)10705030100009(11)150922
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 06/21/2016

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 Lot Number: REQUESTED NOT PROVIDED-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2016
• Initial Date FDA Received: 07/20/2016
• 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): Hospitalization
• Patient Age: 53 YR
• Patient Weight: 50