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

Lot Number D329/118 - KIT

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

Patient Problems Fever (1858); Sepsis (2067); Chills (2191)

Event Date 08/10/2015

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.A review of kit lot d329 was performed.There were no nonconformances associated with this lot.This lot met release requirements.The uvadex lot number was not provided.However, a review of all uvadex lots manufactured since january 2013 was performed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for complaint categories, chills, fever, and sepsis.No trends were detected.No corrective and preventive actions have been initiated for these complaint categories.Based on internal medical assessment, child patient developed chills, shivers, rigors, and high temp during ecp procedure, photoactivation stage (approximately 15 minutes left of the photoactivation, and the high temp was recorded at approximately 10 minutes after initial symptom presentation).Customer reported patient had sepsis, was admitted to the hospital.Physician stated patient "grew gram negative bacilli" in her blood cultures "with in four (4) hours" after the blood sample was taken on (b)(6) 2015.Patient was on heparin.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 is no device malfunction.The ae is related to the patient's underlying condition of sepsis.However, this event occurred during treatment and the patient was hospitalized.Therefore, this case is being reported as an mdr.The assessment is based on information available at the time of the investigation.No product was returned by the customer for investigation.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continuous improvement process.Kit unique identifier (udi)#: (b)(4).Adverse event term: (b)(4) - sepsis.(b)(4).Device not returned.

Event Description

Customer called to report child patient had symptoms of chills, shivers, rigors, and high temp during ecp procedure, photoactivation stage.Customer reported the symptoms of chills, shivers, and rigors began with approximately 15 minutes left of the photoactivation, and the high temp was recorded at approximately 10 minutes after initial symptom presentation.Customer reported remaining time of photoactivation was completed, and treated cells were reinfused back to the patient.Customer reported patient had sepsis, was admitted to the hospital.Customer stated they would not provide further information specifically about this patient, as per instructions received from their medical director.The customer declined to send the procedural kit or smart card back to therakos.Customer stated the patient "grew gram negative bacilli" in her blood cultures "within four (4) hours" after the blood sample was taken on (b)(6) 2015.The physician requested that therakos not contact customer any further in regards to this case as per instructions she received from the medical director.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS INC.; 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: 5021986
• MDR Text Key: 23730774
• Report Number: 2523595-2015-00223
• 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: Nurse
• Report Date: 08/10/2015

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: Nurse
• Device Expiration Date: 05/01/2017
• Device Lot Number: D329/118 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• 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