MAUDE Adverse Event Report: THERAKOS, INC XTS PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Chest Pain (1776); Hypoglycemia (1912); Low Blood Pressure/ Hypotension (1914); Nausea (1970)

Event Date 02/14/2017

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.A device history review was performed.The instrument has been located at the customer's site since 06/28/2007.The customer has their own trained biomed that performs any necessary service on this instrument.Trends were reviewed for complaint categories, buffy volume exceeded alarm, blood pump error alarm, chest pain, nausea, hypotension, and other adverse event: hypoglycemia.No trends were detected for these complaint categories.From a device perspective: since the device cannot be ruled out as a possible contributing factor to this event, this case will be reported as a mdr.This case is also reportable as a mdr due to the medical intervention of the aspirin, o2, and food that was given to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.The assessment is based on information available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Adverse event terms: chest pain, nausea, hypotension, and hypoglycemia.(b)(4).

Event Description

The customer called to report a buffy volume exceeded alarm and the customer wanted to know if they could go to photoactivation.The customer stated that there were no red blood cells or buffy coat collected in the recirculation bag.The customer reported that the patient's plasma was slightly cloudy.The customer was informed that if a buffy coat has not been collected, then they should not photoactive what has been collected in the recirculation bag.The customer stated that they understood.The customer reported that at that moment the patient began experiencing chest pain.The customer stated that shortly after ending the procedure in order to return the blood/products to the patient, the patient started complaining of chest pain and nausea.The customer reported that the hospital's rapid response team was called.The customer stated that the rapid response team performed an ekg on the patient and the ekg was normal.The customer reported that the rapid response team provided both oxygen and aspirin to the patient.The customer stated that the patient's blood pressure had dropped to 79/42.The customer reported that they increased the return rate on the instrument in order to have a faster return of all blood/products to the patient due to the patient's low blood pressure.The customer stated that the patient was transported to the emergency room.The customer reported that the patient's blood pressure had increased to 95/54 and their blood sugar was 139 right before they were taken to the emergency room.The customer stated that the patient did not have any complaints prior to starting the procedure.However, the patient's blood sugar was 66 so they gave the patient some yogurt and something else (did not specify).The customer reported that the patient was a little sleepy and burping often during the procedure.The customer stated that they had two blood pump error alarms prior to the event.The customer reported that the blood pump error alarms were between cycle one and two of the procedure.The customer stated that they were able to clear the alarms by doing a saline bolus each time.The customer reported that the buffy volume exceeded alarm had also occurred prior to the event.In addition, the customer stated that the patient's access line was sluggish every now and then so at each time they had to flush the patient's access.The customer reported that there was no clotting or occlusions noted in the kit.The customer stated that they returned all blood/products to the patient, however no drug was administered.The customer stated that she was not aware of any medical interventions that were provided to the patient while the patient was in the emergency room.The customer reported that the patient's troponin enzyme level, which was tested when the patient was taken to the emergency room, was 0.02.The customer stated that they will not be returning any product.The instrument was not returned for investigation.

• 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: 6397594
• MDR Text Key: 69738987
• Report Number: 2523595-2017-00050
• Device Sequence Number: 1
• Product Code: LNR
• 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: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: XTS
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2017
• Initial Date FDA Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 86