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

Lot Number D357-KIT

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem Hyperglycemia (1905)

Event Date 02/09/2016

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A review of kit lot d357 was performed.There were no non-conformances related to this lot.This lot met all release requirements.The uvadex lot number was not provided, since uvadex was not administered.However, a review of all uvadex lots manufactured since january 2013 was performed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for complaint categories, drive tube leak/break and alarm #7: blood leak? (centrifuge chamber).No trends was identified for these categories.A corrective and preventive action was initiated for complaint category, drive tube leak/break.Evaluation of the returned photographs is still in progress at the time of the report.A supplemental report will be filed when this analysis is complete.Meddra codes: (b)(4).Kit unique device identifier:(b)(4).Device not returned for evaluation.

Event Description

The customer called to report a drive tube break and leak that occurred at approximately 300 ml during a patient treatment.The operator reported the break occurred near the drive tube clamp assembly.The nurse who installed the kit reported it felt tight as she was installing it.The instrument leak detector was not damaged.Treatment was aborted and the patient's blood product was returned manually.A new treatment was started for the patient on the same instrument.

Manufacturer Narrative

A photo analysis was conducted for this complaint.A review of the photos confirmed the broken/damaged drive tube.The root cause of the leak is, most likely, bearing stop delamination which allowed the drive tube to twist against the drive tube clamp; damaging the drive tube and ultimately leading to a leak.A review of the device history record did not identify any related nonconformances.Corrective actions have already been initiated to address the potential root causes of drive tube delamination.(b)(4).Device not returned to manufacturer.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC.; hampton NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 5481070
• MDR Text Key: 40065308
• Report Number: 2523595-2016-00048
• 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
• Type of Report: Initial,Followup
• Report Date: 02/09/2016

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: 09/01/2017
• Device Lot Number: D357-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2016
• Initial Date FDA Received: 03/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• 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: 13 YR
• Patient Weight: 68