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

Lot Number C137-KIT

Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/11/2014

Event Type  malfunction  

Event Description

Customer reported by fax: "buffy coat exceeded at 1637ml wbp.Hematocrit froze at 12% on the screen.Cut bc early, then noticed clear fluid coming from hct sensor and a pool of water (small amount).No more noticed, could not find where this had come from.Treatment completed.Patient was feeling fine".Treatment was in single needle mode, collect rate 25ml/min.Clinical services specialist called customer on (b)(4) for more information: customer noticed some fluid ("few drops") in the hematocrit sensor when she lifted the cuvette out of the sensor housing.She tried to find a cause for the hct curve to freeze at 12%, but could not see anything strange.Customer confirmed it was clear fluid, as a water drop, certainly not blood.Customer carefully examined lines and pto for leaks, but there were none.Customer continued the procedure and during photoactivation placed a tissue under the lines in the area of the fluid.All remained dry, the treatment was therefore completed, the blood returned to the patient.The customer will return the smart card for investigation.There was no service order generated.

Manufacturer Narrative

A review of lot c137 was performed and there was no nonconformances associated with this lot.This lot met release requirements.Trends were reviewed for complaint categories, tubing leak and alarm #10: buffy volume exceeded.No trends were detected.Capa (b)(4) was initiated for tubing leak.This capa has been closed.This assessment is based on information available at the time of the investigation.Evaluation of the smart card is still in progress at the time of this report.A supplemental report will be filed when this evaluation is complete.Kit unique identifier (udi)#: (b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• 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, ste. 140; bridgewater, NJ 08807
• MDR Report Key: 4373682
• MDR Text Key: 17225436
• Report Number: 2523595-2014-00340
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2016
• Device Lot Number: C137-KIT
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2014
• Initial Date FDA Received: 12/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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 Age: 28 YR
• Patient Weight: 72