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

Lot Number D358 - KIT

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

Patient Problem Diarrhea (1811)

Event Date 02/09/2016

Event Type  Injury  

Manufacturer Narrative

This system was used for treatment.Kit lot d358 was reviewed.There were no non-conformances.This lot met all release requirements.The uvadex lot number was not provided as it was not administered.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 low hemoglobin, volume concern, gastrointestinal hemorrhage and diarrhea.No trend was identified for any of these complaint categories.The assessment is based on information available at the time of the investigation.There is no device malfunction.The ae of diarrhea and gi bleed probable cause is the patient's underlying disease.However, medical intervention of blood transfusion and ivig was given to the patient prior to discharge from photopheresis, hence this case is assessed as reportable as an mdr.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continuous improvement process.(b)(4).Device not returned.

Event Description

Customer called to report patient's hematocrit (hct) resulted at 19%.Customer said procedure already started, and requested information on how to end treatment and return blood to the patient.Customer said patient stable during procedure, but was concerned about the amount of the patient's extracorporeal fluid volume in the instrument.Clinical services educator (cse) suggested customer press stop, then toggle the "up/down arrow" operator button to find the "end tx" (end treatment) button.Customer said she successfully stopped the bowl, selected the end treatment button, and the centrifuge bowl was emptying into the return bag.Customer verbalized understanding that patient's hct needs to be at least 27% prior to starting.Customer stated last week the patient's hct was 29%.Customer said physicians were looking into why the patient's hct had dropped to 19%, and were suspecting a "gi bleed." on (b)(6), customer called back to report further details.Customer said that during the procedure, they drew another cbc.Customer said the patient's hematocrit was 16% and hemoglobin was 5.1.Customer said the patient was stable, and was asymptomatic during procedure.Customer said patient had active diarrhea for several days, and that the patient reported the diarrhea as "dark." customer said patient was transferred in stable condition to an infusion center to receive ivig and a blood transfusion while waiting to be admitted to the hospital.Customer said the reason for hospital admission is to rule out a gi bleed.Customer said they do not think the patient's low hematocrit and possible gi bleed was a result of the photopheresis procedure.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC; hampton NJ 08827
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave; buffalo NY 14211
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 5483936
• MDR Text Key: 39799081
• Report Number: 2523595-2016-00043
• 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
• Type of Report: Initial
• Report Date: 02/09/2016

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 Expiration Date: 09/01/2017
• Device Lot Number: D358 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2016
• Initial Date FDA Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• 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
• Patient Age: 44 YR
• Patient Weight: 77