MAUDE Adverse Event Report: THERAKOS, INC XTS PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Air Leak (1008); Break (1069); Leak/Splash (1354); Occlusion Within Device (1423); Device Displays Incorrect Message (2591)

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

Event Date 01/17/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction of the tubing leak, and this reportable malfunction is only associated with the kit.A batch record review of kit lot e727 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot e727 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories, air detected alarm and tubing leak.No trends were detected for these complaint categories.The assessment is based on information available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.(b)(4) device not returned to manufacturer.

Event Description

The customer called to report a tubing leak just below the anticoagulant (a/c) drip chamber.The customer stated that there was air in the a/c tubing line and that an air detected alarm occurred.The customer reported that while they attempted to strip the air out of the a/c line; the tubing broke just below the a/c drip chamber.The customer stated that they wanted to perform a manual blood return, however the customer was advised to aborted this treatment with no blood/product returned to the patient as the kit was no longer considered sterile.The treating physician reported that he agreed that the blood should not be returned to the patient.The physician stated that the patient could tolerate the blood loss thus no transfusion was required.The kit was not returned for investigation.

• Brand Name: XTS PHOTOPHERESIS SYSTEM
• Type of Device: XTS PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC; hampton NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; po box 9001; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 6330838
• MDR Text Key: 67660195
• Report Number: 2523595-2017-00032
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200027
• UDI-Public: (01)20705030200027(10)E727(17)210701
• 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
• Report Date: 02/15/2017

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: 07/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: XT125
• Device Lot Number: E727
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2017
• Initial Date FDA Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2016
• 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