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

Lot Number D317 - KIT

Device Problems Device Alarm System (1012); Crack (1135); Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/20/2015

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot d317 was performed.There were no non-conformances associated with this lot.This lot met 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 non-conformances related to the complaint were noted.Trends were reviewed for complaint categories, drive tube leak/break and alarm #18: system pressure and no trends were detected.However, a corrective and preventive action has already been initiated for complaint category, drive tube leak/break.A photo analysis was conducted.Review of the photographs confirmed the reported drive tube damage.However, the analysis was unable to determine the root cause of the leak.Review of the device history record did not identify any related non-conformances during manufacturing.No manufacturing related defects were confirmed during the evaluation.Based on the analysis, no remedial actions will be conducted.Complaints of this nature are monitored through tracking and trending.Should a trend arise, further action will be taken.(b)(4).Not returned.

Event Description

Customer called to report drive tube leak that occurred on (b)(6) 2015 during treatment procedure.Customer stated drive tube looked like it had a crack in it.Treatment was in single-needle mode.There had been 333 ml whole blood processed.Customer stated the patient was fine.They aborted the treatment procedure with no return of blood/products to the patient.Customer stated they were able to treat the patient starting a second procedure.Customer stated no there was no clotting or occlusions noted in kit.There were no alarms during prime or prior to blood leak.Customer stated she heard a noise in the instrument and then a system pressure alarm occurred.Customer cleaned the instrument and was able to start a new procedure on the same instrument, which completed successfully.The customer sent photographs for investigation.

• 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 bailey ave.; buffalo NY 14211
• Manufacturer Contact: dianna inguanzo ; 10 north high street; suite 300; west chester, PA 19380
• MDR Report Key: 5003358
• MDR Text Key: 24789465
• Report Number: 2523595-2015-00216
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: 10705030100009
• 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 faci
• Reporter Occupation: Nurse
• Report Date: 07/21/2015

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: D317 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 63 YR
• Patient Weight: 79