MAUDE Adverse Event Report: THERAKOS, INC. THERAKOS CELLUX PHOTPHERESIS SYSTEM; CELLEX ECP SYSTEM

Catalog Number 6661

Device Problems Leak/Splash (1354); Component Missing (2306)

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

Event Type  malfunction  

Event Description

Customer reported a photo activation module leak directly to (b)(4) on (b)(6) 2014.The customer did not report the event directly to therakos.Name and function of complainant: same as reporter.Letter from (b)(4) was received by therakos on (b)(6) 2014 to notify that the customer had reported the event.The delay in documentation was due to the instrument serial number missing.Therakos css contacted (b)(4) (contact on (b)(4) letter) on (b)(6) 2014 to get the serial number and any additional information.No answer was received.Therakos css called the customer, nurse (b)(6), on (b)(6) 2014 but she had little time to provide additional information.The nurse reported that there was a photoactivation leak that was reported directly to (b)(4) on (b)(6) 2014 but she could not provide the exact date that the event occurred.Nurse (b)(6) stated that the exact date that the event occurred.Nurse (b)(6)state that the patient was fine.She was asked but did not provide any additional patient or event information.

Manufacturer Narrative

A review of lot file b110 was performed.There were no nonconformances reported for this lot.This lot met all release requirements.A complaint lot review of b110 was conducted and there were no other photoactivation module leaks reported at the time of investigation for this lot.No trends were detected.The assessment is based on information available at the time investigation.No product was returned by the customer.Therefore, the root cause for the photoactivation module leak could not be determined based solely on the information provided.(b)(4).

• Brand Name: THERAKOS CELLUX PHOTPHERESIS SYSTEM
• Type of Device: CELLEX ECP SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEICAL PRODUCTS; 2201 bailey avenue; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east; suite 140; bridgewater, NJ 08807 ; 9083675452
• MDR Report Key: 3755391
• MDR Text Key: 16804922
• Report Number: 2523595-2014-00057
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Other
• Type of Report: Initial
• Report Date: 01/17/2014

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: 11/01/2015
• Device Catalogue Number: 6661
• Device Lot Number: B110-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2014
• Initial Date FDA Received: 02/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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