MAUDE Adverse Event Report: MACK MOLDING COMPANY CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM

Catalog Number CELLEX

Device Problem Use of Device Problem (1670)

Patient Problem Pulmonary Embolism (1498)

Event Date 08/11/2023

Event Type  Injury  

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced a pulmonary embolism following their ecp treatment procedure.The customer stated that an alarm #18: system pressure alarm occurred at the beginning of the patient's ecp treatment procedure after 417ml of whole blood processed and they could not reset the alarm.The customer reported that they flushed the patient's access line and attempted to reset the alarm; however, the alarm continued to occur.The customer stated that they then noticed some clotting in both the cellex kit's centrifuge bowl and return bag.The customer reported that they aborted the patient's ecp treatment procedure without any blood returned to the patient.The customer stated that the anticoagulant bag was correctly installed on the cellex instrument.The customer reported that they suspected that their pharmacy did not include the heparin in their anticoagulant bag.The customer stated that their pharmacy had to alter their usual procedures due to a recent cyber-attack.The customer reported that the patient was asymptomatic; however, due to the clotting found in the cellex kit, the patient's treating physician sent the patient to the emergency room for a computerized tomography (ct) angiogram to check for clots in the patient's lungs.The customer confirmed that the patient had no symptoms, and the testing was only precautionary.In a follow up with the customer on (b)(6)2023, the customer reported that the patient's ct scan found low grade clotting in both the patient's left and right lower lobes of their lungs.The customer stated that the patient was started on the anticoagulant medication, eliquis.The customer reported again that they believed that their pharmacy did not properly prepare their anticoagulant bag; however, due to their computer system being hacked and down they had no way to confirm this suspicion.No product was returned for investigation.

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the medical intervention of the anticoagulant medication, eliquis, that was provided to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.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 (b)(6)2015.As part of the review, it was determined that the instrument's last service prior to the event was on (b)(6)2023.During this service the system checkout procedure was successfully completed indicating that the instrument had passed all tests, met all specifications, and was operational.The most likely root cause for the alarm #18: system pressure alarm was the clots observed in both the cellex kit's centrifuge bowl and return bag.The root cause for the clot observed and the patient's pulmonary embolism could not be determined as no product was returned for investigation and no instrument service was requested by the customer or performed by therakos as a result of this incident.However, the customer reported that they suspected that their pharmacy did not include the heparin in their anticoagulant bag.The customer stated that their pharmacy had to alter their usual procedures due to a recent cyber-attack.The customer reported that due to their computer system being hacked and down they had no way to confirm this suspicion.Thromboembolic events are a labelled side effect of the therakos® cellex® photophoresis system.In the cellex operator manual, section 2-9 anticoagulation, the caution section states "special attention to adequate anticoagulation is advised when treating patients with gvhd, a condition associated with an increased risk of thromboembolic events.Thromboembolic events (including pulmonary embolism and deep vein thrombosis) have been reported with the use of the therakos® cellex® photophoresis system in the treatment of gvhd an indication which is not approved in the us." trends were reviewed for complaint categories alarm #18: system pressure, 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: pulmonary embolism.(b)(4).10-sep-2023.

• Brand Name: CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): MACK MOLDING COMPANY; 608 warm brook rd; arlington VT 05250
• Manufacturer (Section G): MACK MOLDING COMPANY; 608 warm brook rd; arlington VT 05250
• Manufacturer Contact: mark wendelken ; 440 route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 17722338
• MDR Text Key: 323107009
• Report Number: 3013428851-2023-00051
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• 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: 09/10/2023

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 Catalogue Number: CELLEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2023
• Initial Date FDA Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2015
• 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: 57 YR
• Patient Sex: Male