MAUDE Adverse Event Report: THERAKOS XTS PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction centrifuge bowl leak/break.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.A batch record review for kit lot f704 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of f704 for the reported issue shows no trends.Trends were reviewed for complaint categories, noise, occlusion system alarm, leak centrifuge alarm, and centrifuge bowl leak/break.No trends were detected for each complaint category.This assessment is based on the information available at the time of the investigation.At the time of this report, the analysis of the customer provided photos is still in progress.A supplemental report will be filed when the analysis is complete.(b)(6).

Event Description

The customer called to report a centrifuge bowl leak/ break.During cycle 6 of the treatment, the customer heard a loud noise, following the loud noise sounded an occlusion system alarm.The alarm was silenced.From there a leak centrifuge alarm had occurred, this is when the blood was observed in the centrifuge and the surrounding areas.The treatment was aborted with no blood returned back to the patient.The patient was in stable condition and not affected by the incident.The customer has provided photographs to be investigated.

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction centrifuge bowl leak/break.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.Kit lot f704 was reviewed.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot f704 identified an increase in complaints associated with the centrifuge bowl leak/break complaint category.An investigation has been initiated in response to the increase of centrifuge bowl leak/break complaints observed with kit lot f704.Trends were reviewed for complaint categories, noise, occlusion system alarm, leak centrifuge alarm, and centrifuge bowl leak/break.No trends were detected for each complaint category.A photograph and video analysis was conducted for this complaint.A review of the customer provided photographs and video confirms the reported blood leak in the centrifuge chamber.However, the origin of the leak could not be determined based on the provided photographs, video and available information.A material trace used to build kit lot f704 found no related nonconformances.The device history record review did not result in any related non-conformances and this kit lot had passed lot release testing.The root cause of the following centrifuge bowl leak/ break could not be determined.No further action required.Investigation complete.(b)(4).

• Brand Name: XTS PHOTOPHERESIS SYSTEM
• Type of Device: XTS PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• Manufacturer (Section G): THERAKOS, INC; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 7112875
• MDR Text Key: 95770966
• Report Number: 2523595-2017-00228
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200027
• UDI-Public: (01)20705030200027(10)F704(17)220301
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 03/01/2022
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: XT125
• Device Lot Number: F704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 63