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

Lot Number B902 - KIT

Device Problems High Test Results (2457); Device Operates Differently Than Expected (2913)

Patient Problems Bacterial Infection (1735); Fever (1858); Unspecified Infection (1930)

Event Date 08/28/2014

Event Type  Injury  

Event Description

Customer had observed fever 39-40 degrees celsius and increased crp values for a patient the night after ecp.Customer wanted to know whether there is literature regarding crp values and ecp.Customer was provided with information from medical affairs including relevant literature.Customer reported that gram-positive cocci were detected in blood cultures and that they concluded that catheter-related sepsis is the cause.The patient was hospitalized after the treatment and was started on iv broad-spectrum antibiotics.This was later changed to staphylex (narrow spectrum antibiotic against common gram-positive organisms).It was reported that the patient would be treated with iv-antibiotics for 14 days and will then go home for two weeks.He will receive ecp again afterwards, with peripheral access.The patient's current condition was reported to be good.

Manufacturer Narrative

A review of lot b902 was performed.There were no nonconformances associated with the lot met release requirements.Trends have been reviewed for the relevant complaint categories and no trends were detected for fever, chills, central line infection, or other adverse event.This assessment is based on information available at the time of this report.No product was returned for evaluation; therefore, it could not be determined if this specific product met specifications.The increase in crp is, most likely, related to the sepsis and not directly to ecp.This incident is being reported because hospital admission occurred with medical intervention.

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave.; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east, suite 140; bridgewater, NJ 08807
• MDR Report Key: 4122369
• MDR Text Key: 21494332
• Report Number: 2523595-2014-00242
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P680003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/28/2014

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: Health Professional
• Device Expiration Date: 09/01/2018
• Device Lot Number: B902 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2014
• Initial Date FDA Received: 09/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 72