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

Model Number NOT APPLICABLE

Device Problems Fluid/Blood Leak (1250); Occlusion Within Device (1423); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

System was used for treatment.Kit lot e715 was reviewed.There were no non-conformances.This lot met all release requirements.Trends were reviewed for complaint categories occlusion system alarm, leak centrifuge alarm and centrifuge bowl leak/break and no trend was detected for these categories.This assessment is based on the information available at the time of the investigation.No product was returned by the customer for investigation; therefore, it could not be determined if this specific product met specification.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Investigation completed.(b)(4).

Event Description

Customer called to report occlusion system alarm during 1st cycle buffy coat.Customer flushed the patient access, did 2 saline boli, and resumed treatment.Customer then received leak centrifuge alarm and noted some blood leak in the centrifuge.Customer will restart the patient on another kit.Customer declined service at this time.The customer will not return the kit for investigation as it has already been discarded.

• Brand Name: XTS PHOTOPHERESIS SYSTEM
• Type of Device: XTS PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; 10 north high street, suite 30; west chester PA 19380
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street, suite 30; west chester PA 19380
• Manufacturer Contact: megan vernak ; 53 frontage road; po box 9001; hampton, NJ 08827
• MDR Report Key: 6213796
• MDR Text Key: 63835887
• Report Number: 2523595-2016-00287
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200027
• UDI-Public: (01)20705030200027(10)E715(17)210401
• 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: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 04/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: XT125
• Device Lot Number: E715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2016
• 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
• Patient Age: 39 YR
• Patient Weight: 80