MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems Fainting (1847); Dizziness (2194)

Event Date 05/26/2017

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the medical intervention of the saline bolus that was given to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.A device service history review was performed.The instrument has been located at the customer's site since (b)(6) 2015.The instrument's last service was completed on 05/26/2017, right after the event occurred.A complete checkout of the instrument was performed and no issues were found with the instrument.One pump required a slight adjustment.During this service the system checkout procedure was successfully completed indicating that the instrument had passed all tests, met all specifications, and was operational.Trends were reviewed for complaint categories, alarm #19: fluid balance limit, dizziness, and fainting.No trends were detected for these complaint categories.The smartcard data was reviewed.An alarm #7: blood leak (centrifuge chamber) alarm occurred before the prime was started.This is a sign that the operator was testing the leak sensor prior to the start of the treatment.The prime was completed without incident.The operator then changed the setup of the procedure.The operator changed the anticoagulant ratio to 12:1 and raised the return bag threshold to 500 ml.The collection was started in single needle mode, and the purging air phase was completed after 18 ml of whole blood processed.An alarm #19: fluid balance limit alarm for a fluid balance of -501ml occurred after 501 ml of whole blood processed.The operator then reduced the return bag threshold to 100ml.A second alarm #19: fluid balance limit alarm occurred and the operator ended the treatment.A review of the photos indicated that the fluid balance limit threshold was set to +/- 500ml thus the instrument alarmed appropriately when the patient's fluid balance reached -501ml.The root cause for this event was operator error.The customer changed the treatment bag's threshold to 500ml at set up which allowed the instrument to continue to collect but not return to the patient.The customer did decrease the treatment bag's threshold to 100ml after the first alarm #19: fluid balance limit alarm, however the return flow rate was set to 0.0 ml/min and another 200mls of blood was collected from the patient.A second alarm #19: fluid balance limit alarm occurred.The customer ended the treatment and raised the return flow rate to 50 ml/min.According to the smartcard, the patient received all of their fluids and had a positive fluid balance at the end of the procedure.The operator's manual (section 5-17) recommends "to minimize extracorporeal volume (ecv), set the return bag threshold value to 100ml." adverse event terms: dizziness and fainting.(b)(4).

Event Description

The customer called to report an alarm #19: fluid balance limit alarm.The customer reported that they had increased the collect rate to 50 ml/min after the purging air phase of the single-needle mode treatment had been completed.The customer stated that they then went to check the patient's blood pressure.The customer reported that at about 400ml of whole blood processed, the patient complained of feeling dizzy.The customer stated that as the patient reached over to get a water bottle, the patient's head dropped and the patient became unresponsive.The customer reported that the alarm #19: fluid balance limit alarm then occurred at the same time.The customer stated that they started to give the patient a saline bolus via instrument, however one minute into the bolus the rapid response team arrived.The customer reported that the saline bolus was stopped and the rapid response team recommended that the customer not continue on with the treatment.The customer stated that the treatment was aborted with no return of blood/products to the patient.The customer reported that the patient's fluid balance was (-) 450ml.The customer stated that the patient was in stable condition.The customer reported that there were no other alarms during the treatment besides the alarm #19: fluid balance limit alarm.The customer stated that the single needle mode configuration was setup correctly, and that the return bag threshold volume was set to 100 ml.Service was requested.The customer reported that the kit had already been discarded.The smartcard and photos were submitted for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX 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: 6665652
• MDR Text Key: 78350144
• Report Number: 2523595-2017-00111
• 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: 06/23/2017

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: CELLEX
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2017
• Initial Date FDA Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2015
• 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): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 54