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

Model Number 6661 INSTRUMENT

Device Problems Fluid/Blood Leak (1250); Material Separation (1562); Device Displays Incorrect Message (2591)

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

Event Date 01/02/2014

Event Type  malfunction  

Event Description

Customer is reporting a centrifuge bowl leak.Customer called to report a bowl separation during the treatment, customer reported, he installed the kit and it was installed correct.Customer stated the only alarms experienced before the bowl leak was collect and return pressure alarms that were cleared.Service order# (b)(4) was dispatched to inspect the instrument.Customer submitted photos for investigation.

Manufacturer Narrative

A batch record review for lot file for b345 was performed.There were no non-conformances for this lot.This lot met all release requirements.A review of complaints received for lot b345 was performed.There were no other centrifuge bowl leaks reported to date for this lot.No trends detected.Service order (b)(4): field engineer found pressure transducer out of range replaced drive tube clamps damaged, replaced and leak strip damaged replaced.After repair it was able to run section checkout without error.Repairs have returned this instrument to expected operation.This assessment is based on the information available at the time of the investigation.The submitted photographs were analyzed.The kit was not received for analysis.A leak was confirmed, but a root cause could not be determined.A more thorough analysis would have been possible if the kit had been returned for examination.No remedial action was taken.Complaints of this nature are monitored through tracking and trending.Should a trend arise, further action will be taken.(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 ave.; buffalo NY 14211
• Manufacturer Contact: 440 us route; east suite 140; bridgewater, NJ 08807 ; 9083675452
• MDR Report Key: 3786661
• MDR Text Key: 18569767
• Report Number: 2523595-2014-00052
• 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: 01/02/2014

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 Model Number: 6661 INSTRUMENT
• Device Lot Number: B345 KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2014
• Initial Date FDA Received: 02/06/2014
• 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
• Patient Age: 54 YR