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

Lot Number D902 - KIT

Device Problems Fogging (1253); Device Displays Incorrect Message (2591); Temperature Problem (3022); Noise, Audible (3273)

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

Event Date 03/30/2016

Event Type  malfunction  

Manufacturer Narrative

This system was used for treatment.Kit lot d902 was reviewed.There were no non-conformances.This lot met all 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 all complaint categories and no trends were detected for complaint category centrifuge bowl leak/break or leak centrifuge alarm.Service order feedback is still pending at the time of this report.A supplemental report will be sent once service order feedback is received.This assessment is based on 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 through the capa/continuous improvement process.(b)(4).Device not returned.

Event Description

Customer reported a leak centrifuge alarm just before collection of the buffy code (bc) in the first cycle.She also states there was an abnormal sound in the centrifuge chamber, it seemed like heating up and the glass lid was fogged.Treatment was aborted and no blood was returned to the patient.Patient is in stable condition, no further details were provided.Customer requested service, service order (so) will be dispatched.

Manufacturer Narrative

Service order (b)(4) completed: service engineer replaced vacuum pump and performed system checkout procedure successfully.(b)(4).Debvice not returned.

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Type of Device: XTS
• Manufacturer (Section D): THERAKOS, INC; hampton NJ 08827
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave; buffalo NY 14211
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 5611311
• MDR Text Key: 44698691
• Report Number: 2523595-2016-00101
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100016
• UDI-Public: 10705030100016
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/30/2016

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: 03/01/2016
• Device Lot Number: D902 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2016
• Initial Date FDA Received: 04/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2016
• 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: 66 YR
• Patient Weight: 90