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

Lot Number D313 - KIT

Device Problems Crack (1135); Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

Patient Problem Blood Loss (2597)

Event Date 05/15/2015

Event Type  malfunction  

Event Description

Customer reported an acceleromter alarm (alarm #46) had occurred when the double needle mode treatment had reached 1328 ml whole blood processed.Customer followed the recommended troubleshooting actions.While checking the bowl and drive tube, customer noticed a blood leak had occurred in the centrifuge.Treatment was aborted and the blood in the kit was not returned to the patient.Customer stated there had not been any blood leak alarms.Customer stated the bowl did not appear damaged, but the drive tube appeared to be cracked.Customer stated the leak sensor strip was not damaged.Customer indicated they would clean the centrifuge and no field service is being requested at this time.Estimated blood loss is approximately 377 ml.Customer reported the (b)(6) male patient was stable.Customer returned the kit and provided photos for investigation.

Manufacturer Narrative

Device was used for treatment.A batch record review was performed for lot d313.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 noncoformances related to the complaint were noted.Trends were reviewed for all complaint categories and no trend was detected for drive tube leak/break nor for alarm #46: accelerometer system alarm.A corrective and preventive action has been initiated to investigate drive tube leak/breaks and a corrective and preventive action has been initiated for alarm #46: accelerometer system alarm as well.This assessment is based on the information available at the time of the investigation.Analysis of the kit and smart card provided by the reporter is still in progress at the time of this report.A supplemental report will be filed when the investigation is complete (b)(4).

Manufacturer Narrative

The kit was returned for analysis.Review of the returned kit components confirmed the reported leak.Further analysis found the root cause of the leak was delamination of the upper bearing stop from the drive tube.The bearing stop delamination allowed the drive tube to rub against the wall of the centrifuge chamber, damaging the drive tube and causing a leak.Corrective and preventive actions have been initiated and are ongoing to address potential root causes of drive tube delamination.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave; buffalo NY 14211
• Manufacturer Contact: dianna inguanzo ; 10 north high street; suite 300; west chester, PA 19380
• MDR Report Key: 4838904
• MDR Text Key: 20030068
• Report Number: 2523595-2015-00178
• Device Sequence Number: 1
• Product Code: LNR
• 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 Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/15/2015

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: Nurse
• Device Expiration Date: 03/01/2017
• Device Lot Number: D313 - KIT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2015
• Initial Date FDA Received: 06/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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 Age: 41 YR