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); Chest Pain (1776)

Event Date 01/23/2019

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to both the patient's hospitalization and the medical intervention of the nitroglycerin, dalteparin, enoxaparin, and oxygen 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 distributor.No service was requested by the distributor for this adverse event.The distributor has their own in house biomed who performs all the service for this instrument.The smart card data for the patient's (b)(6) 2019 treatment was reviewed.Prime was completed without incident and collection was started in single needle mode.An alarm 16: collect pressure alarm occurred twice during the treatment.Each time the alarms were resolved and the treatment continued.The buffy coat was collected and photoactivation occurred without incident.The treatment ended automatically, as expected with all blood and treated cells returned to the patient.Based on the smart card data, there was no indication of an issue with either the instrument or treatment thus the root cause for this event could not be determined.Trends were reviewed for complaint categories, chest pain 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: chest pain and pulmonary embolism (b)(4).

Event Description

The distributor reported that an extracorporeal photopheresis (ecp) patient experienced chest pains and a pulmonary embolism (pe) following a treatment procedure.The distributor stated that the patient had undergone 54 ecp treatment procedures with the patient's last ecp treatment procedure occurring on (b)(6) 2019.The distributor reported that the patient's (b)(6) 2019 treatment procedure used heparin as the anticoagulant at a 10:1 ratio and this treatment was successfully completed without any alarms or complications.The distributor reported that at the end of this treatment procedure, the patient complained of chest pain and was taken to the emergency department.The distributor stated that the patient received an infusion of nitroglycerin for his chest pains.The distributor reported that the patient was admitted to the hospital on (b)(6) 2019 due to his chest pains.The distributor stated that while in the hospital, the patient underwent a chest computed tomography using an intravenous contrast media following the angiotac protocol, which diagnosed a pulmonary artery thromboembolism in the patient's left apicoposterior segment.The distributor reported that the patient's chest pain was due to their pulmonary embolism.The distributor stated that the patient received a formulation of dalteparin for their pulmonary embolism and the patient also received continuing anticoagulation through 60mg of enoxaparin every 12 hours.The distributor reported that the patient had been placed on permanent oxygen following this event.The distributor stated that the patient was discharged from the hospital the week of (b)(6) 2019 and is in stable condition.The distributor reported that the patient would continue with their ecp treatment procedures on (b)(6) 2019.The distributor stated that the patient did not have a medical history of either thrombosis or pulmonary embolism.The distributor stated that the patient's apheresis physician believed that the patient's ecp treatment procedure could have caused or contributed to both the patient's chest pain and pulmonary embolism.The smart card for the patient's ecp treatment procedure on (b)(6) 2019 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: 8361970
• MDR Text Key: 136880574
• Report Number: 2523595-2019-00029
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: (01)10705030100009(11)170127
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 01/24/2019
• Initial Date FDA Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 70