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); Malaise (2359); Pallor (2468); No Code Available (3191)

Event Date 10/22/2018

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 infusion 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 23-aug-2017.As part of the review, it was determined that the instrument's last service was on 01-aug-2018.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, pale, hazy, malaise, 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%)".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: pallor, other: hazy, malaise, and hypotension.Mc (b)(4), (b)(4) 11/18/2018.

Event Description

The customer called to report that a patient experienced paleness, haziness, malaise, and hypotension during an extracorporeal photopheresis (ecp) treatment procedure.The customer stated that the treatment was proceeding well with no alarms or issues.However, after 1200mls of whole blood processed the customer reported that the patient began to look pale.The customer stated that the patient complained of feeling hazy and generally not well.The customer reported that the patient's blood pressure reading at this moment was 60/30.The customer stated that they paused the treatment in order to give the patient a saline infusion and the patient stabilized.The customer reported that they then ended the treatment with blood returned to the patient.The customer reported that the patient was in stable condition.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: 8082664
• MDR Text Key: 127857474
• Report Number: 2523595-2018-00165
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: (01)10705030100009(11)170408
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2018
• 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: 10/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2017
• 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: 74