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 Pulmonary Embolism (1498); Dyspnea (1816); Thrombosis (2100); Anxiety (2328); Distress (2329); Discomfort (2330); Chest Tightness/Pressure (2463); No Code Available (3191)

Event Date 04/25/2019

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the patient's hospitalization and the medical intervention of the heparin drip and rivaroxaban that were 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 02-feb-2017.As part of the review, it was determined that the instrument's last service prior to the event was on (b)(6) 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,shortness of breath, cough, chest heaviness, anxiety, thrombosis, clot observed, and pulmonary embolism.No trends were detected for these complaint categories.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: dyspnea, no code available: cough, chest tightness/pressure, anxiety, thrombosis, and pulmonary embolism.(b)(4).On 05/24/2019.

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced shortness of breath, cough, chest heaviness, anxiety, a thrombosis, and a pulmonary embolism (pe) following a treatment procedure.The customer stated that the patient was getting hooked up to the instrument for their ninth ecp treatment procedure when they drew a large clot out of the lumen of the catheter as they were drawing blood for her pre-labs.The customer reported that the patient then developed the symptoms of a pe.The customer stated that the patient experienced shortness of breath, cough, chest heaviness, and anxiety.The customer reported that the patient was sent to the emergency room and was then admitted to the hospital for a pulmonary embolism.The customer stated that while the patient was in the emergency room, an ultrasound was performed which found a large clot around the outside of the patient's catheter which was located within her internal jugular vein.The customer reported that a ventilation-perfusion (vq) scan was performed which showed a high probability of a pe.The customer stated that the patient had not been on any anticoagulants.The customer reported that the patient was first administered a heparin drip and then was converted to rivaroxaban while in the hospital.The customer stated that the patient was discharged from the hospital on (b)(6) 2019 with rivaroxaban (15mg bid for 21 days, then 20 mg daily).The customer reported that the patient continues to be stable with some cough and dyspnea on exertion which the patient had prior.The customer stated that the patient's catheter remains in place since the patient's thrombosis was found above the line.The customer reported that the patient's last ecp treatment procedure prior to their thrombosis diagnosis was on (b)(6) 2019.The customer stated that this treatment was successfully completed with all blood and treated cells returned to the patient.The customer stated that they would like to continue with the patient's ecp treatment procedure.The customer reported that they did not know if the patient' ecp treatment procedures could have caused or contributed to the patient's adverse events.The customer stated that although their patients sometimes get a deep vein thrombosis a pe is very rare.The customer stated that there was a high probability that this patient had a pe since the patient had the symptoms of pe plus the vq scan results.No product was returned for investigation.

Manufacturer Narrative

A user facility medwatch was received on 04-jun-2019 which contained additional information regarding this complaint.Trends were reviewed for complaint categories, discomfort and distress.No trends were detected for these complaint categories.Adverse event terms: discomfort and distress.Mc (b)(4).S.K.06/13/2019.

Event Description

A user facility medwatch was received on 04-jun-2019 which contained the following additional information: the customer reported that the patient was experiencing neck discomfort during her ecp treatment procedure and was asked to be seen for a line assessment.The customer stated that the patient had been experiencing discomfort on the right side of her neck with motion, eating and swallowing.The customer reported that the patient's symptoms started three days after her eighth ecp treatment procedure.The customer stated that a large clot was removed from the patient's central line prior to her ninth ecp treatment procedure the customer reported that right after the clot was removed from the patient's central line, the patient became visibly distressed.The customer stated that a stat electrocardiogram was then performed, oxygen was administered to the patient, and a registered respiratory therapist (rrt) was called.

Manufacturer Narrative

A follow-up with the customer concerning this case was performed on 18-jun-2019 which provided additional information regarding this complaint.Mc (b)(4).S.K.06/25/2019.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• MDR Report Key: 8642655
• MDR Text Key: 146218393
• Report Number: 2523595-2019-00068
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: (01)10705030100009(11)161129
• Combination Product (y/n): N
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2019

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: Health Professional
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CELLEX
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2019
• Initial Date FDA Received: 05/24/2019
• Supplement Dates Manufacturer Received: 06/04/2019; 06/18/2019
• Supplement Dates FDA Received: 06/13/2019; 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR