MAUDE Adverse Event Report: THERAKOS, INC XTS PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591); Inadequate User Interface (2958)

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

Event Date 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e902 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot e902 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories, occlusion system alarm and centrifuge bowl leak/break.No trends were detected for these complaint categories.This assessment is based on information available at the time of the investigation.At the time of this report, the data key still has not been received.A supplemental report will be filed when the data key has been received and the analysis of the data key is complete.(b)(4).Device not returned to manufacturer.

Event Description

The customer called to report occlusion system alarms ( x3) that occurred during the first buffy coat collection.The customer stated that they checked the kit for any kinks or clots, but did not note any abnormalities.The customer was asked to remove the centrifuge bowl in order to inspect the centrifuge bowl for clots.The customer reported that he attempted to remove the centrifuge bowl without stopping the centrifuge first.The customer stated that he was unable to remove the centrifuge bowl and now he had "blood on his hands".The customer reported that there was no leak alarm.The customer stated that the treatment was aborted with no blood/products returned to the patient.The customer reported that the patient was in stable condition and was started on another treatment.The customer stated that there was a small blood leak at the top of the bowl after he attempted to remove the bowl without stopping the centrifuge.The customer reported that he was wearing gloves at the time thus there was no blood exposure.The customer stated that he did note an alarm on the instrument's display and the centrifuge had stopped when he opened the centrifuge lid.The customer reported that he did not know what the alarm stated.The customer declined service.The customer has agreed to return the data key for investigation.

Manufacturer Narrative

The data key was received for investigation.A review of the data indicated that a leak centrifuge alarm was the first item on the data key.This was a sign that the operator was testing the instrument's leak sensor prior to the start of the treatment.An occlusion system alarm occurred seventeen minutes after the start of the first collection cycle.A second occlusion system alarm then occurred and the operator responded by pressing the saline key.Three more occlusion system alarms ensued.A bowl vacuum alarm then occurred followed by three centrifuge cover alarms and another bowl vacuum alarm.The occurrence of the occlusion system alarms was confirmed upon review of the data key data, however the cause for these alarms could not be determined based on the information provided.The centrifuge bowl leak/break could not be confirmed based on the available information.However, the customer did acknowledge that they attempted to remove the centrifuge bowl without first stopping the centrifuge.The customer stated that there was a minimal blood leak at the top of the bowl after they attempted to remove it without first stopping the centrifuge.No further action required.This investigation is now complete.Device manufacturer date: 03/19/2016.(b)(4).Device not returned to manufacturer.

• 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: 6227675
• MDR Text Key: 64343796
• Report Number: 2523595-2017-00009
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200010
• UDI-Public: (01)20705030200010(10)E902(17)210301
• 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: 01/05/2017

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: 03/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: XT001
• Device Lot Number: E902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 01/05/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2016
• 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