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

Lot Number C739-KIT

Device Problems Air Leak (1008); Difficult to Remove (1528); Defective Component (2292)

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

Event Date 06/05/2015

Event Type  malfunction  

Event Description

The customer reported through a distributor, a defect on the luer connection of the collection line.When connecting the collection line to the patient, air bubbles were observed during the first extraction.The machine immediately alarmed and the procedure was temporarily interrupted.The customer reported that the luer connection cover had required a greater force to be removed.On (b)(6) 2015, the distributor reported that the treatment was aborted, and that the blood was returned to the patient.There was no loss.The patient was reported to be in stable condition.No service order was generated.Pictures were returned for evaluation.

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot c739 was conducted.There were no nonconformances associated with this lot.The 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 noncoformances related to the complaint were noted.Trends were reviewed for complaint categories, air detected alarm and tubing leak.No trend was detected for these complaint categories.No corrective and preventive actions were initiated for complaint categories, air detected alarm and tubing leak.Product return analysis feedback: a photo analysis was conducted for this complaint.A review of the photographs confirmed a leak at the male luer.However, the root cause of the luer leak could not be determined based solely on the available information.A material trace of lot c739 for the two mating parts found no nonconformances.A review of the device history record did not identify any related nonconformances.This lot passed all lot release testing.No manufacturing defects were identified.However, therakos is reporting this event out of an abundance of caution.All complaints are reviewed with the department operators to make them aware of any defects that can occur.The assessment is based on information available at the time of the investigation.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continuous improvement process.(b)(4).Device not returned to manufacturer.

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Type of Device: XTS
• 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: 4896565
• MDR Text Key: 6831162
• Report Number: 2523595-2015-00200
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2015

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: 07/01/2019
• Device Lot Number: C739-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2015
• Initial Date FDA Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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