MAUDE Adverse Event Report: THERAKOS XTS PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591)

Patient Problem Blood Loss (2597)

Event Date 08/30/2017

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.Kit lot f705 was reviewed.There were no non-conformances.This lot met all release requirements.A review of kit lot f705 shows no trends.Trends were reviewed for complaint categories, noise, leak centrifuge alarm, system error f183: centrifuge speed too slow, centrifuge bowl leak/break.No trends were detected for these complaint categories.This assessment is based on the information available at the time of the investigation.At the time of this report, the analysis of the kit is still in progress.A supplemental report will be filed when the analysis is complete.

Event Description

The customer had called to report a blood leak alarm, a system error and noise coming from the bowl.The customer had mentioned that the centrifuge bowl was checked and there were no leaks or fluids identified.The treatment was in the 5th cycle, platelet count of 400,000 and an hct of 34.1%.The customer had powered off the instrument, removed the bowl to wipe the centrifuge and the bowl with a dry gauze.From there the customer then reinstalled the bowl and powered on the instrument.Customer verified that the centrifuge lid was securely closed, and the system was restarted.A loud noise was then heard from the bowl for about 3 seconds, but the system procedure had continued.The customer had then called back for the same incident to report that a blood leak alarm occurred again and that there was blood seen at the top of the bowl by the connections.The blood was also observed to be found inside of the centrifuge chamber.The customer aborted the treatment without blood return.The patient is in stable condition and was not affected from this incident.The customer has returned the kit for investigation.

Manufacturer Narrative

The kit and corresponding data key have been returned for analysis.The smartcard was reviewed, and it confirmed the occurrence of the blood leak alarms as well as a system error 183: centrifuge spinning too slowly.The corresponding complaint kit was returned intact, and the centrifuge leak was confirmed upon inspection.The dried blood under the top cap of the line and the dried blood running from the top cap to the bottom of the bowl indicated that the blood had leaked out from the bowl seal.The bowl required more torque than typical to rotate the top cap, this was a sign of debris in the bowl seal.The kit was also investigated by the centrifuge bowl supplier.The centrifuge bowl supplier further confirmed a leak had occurred.However, the investigation did not identify any damage to the carbon and ceramic seals in the returned bowl.Furthermore, all critical bowl dimensions were within specification.The bowl manufacturer's product history report was reviewed, and there were no discrepancies that may have contributed to the reported incident.The bowl leak was confirmed, however no root cause could be determined.No further actions are 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: 6898430
• MDR Text Key: 89525087
• Report Number: 2523595-2017-00175
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200027
• UDI-Public: (01)20705030200027(10)F705(17)220301
• 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,Followup
• Report Date: 12/01/2017

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: 03/01/2022
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: XT125
• Device Lot Number: F705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/30/2017
• Initial Date FDA Received: 09/27/2017
• Supplement Dates Manufacturer Received: 11/03/2017
• Supplement Dates FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2017
• 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