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

Model Number 6661

Device Problem Fluid/Blood Leak (1250)

Patient Problem Exposure to Body Fluids (1745)

Event Date 07/01/2013

Event Type  malfunction  

Event Description

The customer reported a blood leak in centrifuge/tubing leak.Name of complainant: same as reporter.Customer reported a blood leak in the centrifuge during a blood prime procedure that was noticed when the treatment had reached 700 ml whole blood processed.Customer stated the patient had been connected at 366 ml whole blood processed.It appears the leak consists of a ring on the centrifuge wall, which dried immediately and did not cause any leak alarm, which no obvious source.The customer could not tell if the leak came from the bowl or the drive tube.No damage was seen to the kit or to the instrument, or to the leak sensor.The customer returned the kit & smart card for investigation.

Manufacturer Narrative

A review of lot file b309 was performed.There were no nonconformances or alarms associated with this event type reported.This lot met all release requirements.A review of complaints reviewed for lot b309 was performed.There were two other reported for tubing leaks to date for this lot.The two tubing complaints were from two different areas of the kit.No trends were detected.This assessment is based on the information available at the time of the investigation.The kit was returned and evaluated.Although the complaint could be consistent with a top (bowl end) bearing stop delamination, no leak was found during analysis.Therefore, the root cause of this failure is undetermined.Complaints of this nature are monitored through tracking and trending.Should a trend arise, further action will be taken.Mxp# (b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX ECP SYSTEM
• Manufacturer (Section D): THERAKOS INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey avenue; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east; suite 140; bridgewater, NJ 08807 ; 9083675452
• MDR Report Key: 3767124
• MDR Text Key: 4553276
• Report Number: 2523595-2013-00229
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P680003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/01/2013

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: 03/01/2015
• Device Model Number: 6661
• Device Lot Number: B309-KIT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/08/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2013
• Initial Date FDA Received: 01/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Weight: 13