MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Vomiting (2144); Malaise (2359)

Event Date 10/03/2018

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 and atropine that was provided to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.From the instrument perspective, there was no known instrument malfunction and no instrument issue was alleged by the customer.No service was requested by the customer for this adverse event.No product was returned; therefore, a device service history review was performed.The instrument has been located at the customer's site since 03-sep-2013.As part of the review, it was determined that the instrument's last service was on 14-dec-2017.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, malaise, vomiting, and hypotension.No trends were detected for these complaint categories.The cellex operator's manual states in section 9: warnings and cautions that "hypotension may occur during any treatment involving extracorporeal circulation.Closely monitor the patient during the entire treatment for hypotension." the operator's manual also states in section 2-4 under adverse reactions that "the side effects of photopheresis (uvadex® used with cellex® systems) were primarily related to hypotension secondary to changes in extracorporeal volume (>1%)".In regards to treating patient's with low body weight, section 10-6 in the operator's manual states "low body weight and obese patients will require slower flow rates to allow time for the physiological adjustments necessary to adapt to the fluid shifts of the procedure." the assessment is based on information available at the time of the investigation.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Adverse event terms: malaise, vomiting, and hypotension.Mc (b)(4).(b)(4) 11/16/2018.

Event Description

The customer reported that a patient experienced malaise, vomiting and hypotension during an extracorporeal photopheresis (ecp) treatment procedure.The customer stated that this was the patient's first ecp treatment for graft versus host disease (gvhd).The customer reported that they were performing a non blood prime procedure and the patient's whole blood processed (wbp) target was set at 1200ml.The customer stated that the treatment was going according to plan with the initial collect/return rate set at 10ml/min which was then raised to 30ml/min.The customer reported that at 1125ml of wbp, the patient began complaining of malaise and started vomiting.The customer stated that the treatment was immediately paused.The customer reported that the patient was then administered extra saline (180ml in 15 minutes) and 0.4mg of atropine.The customer stated that the patient recovered after the administration of the saline and atropine.The customer reported that the treatment was then ended with blood returned to the patient.The customer stated that the patient stabilized and was discharged home.The customer reported that the patient's blood pressure was measured every 15 minutes prior to the incident, and the patient's blood pressure readings prior to the incident were 137/97, 131/104, and 132/104.The customer stated that the patient's blood pressure dropped to 102/63 and then to 63/47 during the incident.The customer reported that the patient's blood pressure was then measured every five minutes after the incident.The customer stated that after the saline and atropine were administered to the patient, the patient's blood pressure raised to 177/119, 158/117, 127/100, and 126/71.The customer reported that the patient has continued with their ecp treatments, but at both a lower collect/return rate (20ml/min) and a lower wbp target volume (1000ml).The customer stated that no further incidents have been reported for this patient.In a follow-up with the customer, the customer reported that the patient was given the atropine due to both the patient's low blood pressure and their vomiting.The customer stated that the patient then stabilized "back to normal." in addition, the patient's caregiver reported that the patient did not eat much before the treatment and thought this could be linked.No product was returned for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• Manufacturer (Section G): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; college business & tech park; cruiserath road; blanchardstown, dublin D15 T X2V; EI D15 TX2V
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 8081340
• MDR Text Key: 127547011
• Report Number: 2523595-2018-00168
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CELLEX
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2013
• 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 Weight: 37