MAUDE Adverse Event Report: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED CELLEX PHOTOPHERESIS SYSTEM

Model Number CELLEXUSA

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

Patient Problems Dyspnea (1816); Pulmonary Edema (2020); Shock (2072); Tachycardia (2095); Low Oxygen Saturation (2477); Multiple Organ Failure (3261); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/23/2021

Event Type  Death  

Event Description

The distributor reported that an extracorporeal photopheresis (ecp) patient experienced dyspnea, oxygen desaturation, pulmonary edema, tachycardia, shock, multiple organ failure, hemophagocytic syndrome, and death following an ecp treatment procedure on (b)(6) 2021.The distributor stated that the patient had been using oxygen prior to starting their ecp treatment procedure.The distributor reported that the patient had complained of shortness of breath the day before his ecp treatment procedure when he was admitted for implantation of his catheter.The distributor stated that at this time it was identified that the patient's oxygen saturation was less than 90%, thus the patient was provided with 2l/min of oxygen daily.The distributor reported that since then, the patient had not been without the oxygen.The distributor stated that the patient was being treated with ecp for lung, eye, and liver graft versus host disease (gvhd).The distributor reported that there had been no alarms during the patient's ecp treatment procedure.However, the distributor stated that upon reinfusion of the treated cells, the patient began to experience dyspnea, basal crackles, and oxygen desaturation.The distributor reported that the patient's 2l/min of oxygen had to be increased to 15l/min in order to maintain an oxygen saturation of 90%.The distributor also stated that lasix 2amp (40mg) in bolus; diphenhydramine 1 amp (50mg); and dimorph 1 amp (2mg) were administered to the patient.The distributor reported that the patient's ecp treatment procedure was completed with both blood and treated cells returned to the patient.The distributor stated that the patient then experienced acute pulmonary edema soon after their completed ecp treatment procedure.The distributor reported that within three hours of their completed ecp treatment procedure, the patient was taken to the intensive care unit (icu).The distributor stated that a chest x-ray and electrocardiogram were performed while the patient was in the icu.The distributor reported that the patient's chest x-ray indicated alveolar pulmonary opacity in the middle third of the right lung with presence of air bronchograms.The distributor stated that the patient's electrocardiogram indicated a heart rate of 131 beats per minute, qrs axis deviation to the right, disturbance in the conduction of the right branch of the hiss beam, and right atrium overload.The distributor reported that the testing also indicated an increase in troponina (1500) and d-dimero (1500).The distributor stated that the patient subsequently required orotracheal intubation on (b)(6) 2021.The distributor reported that the patient then went into shock which required the need for vasoactive drugs.The distributor stated that the patient's medical staff suspected that the patient had a pulmonary thromboembolism; however, they were unable to perform a ct angiography to confirm this due to the patient's instability.The distributor reported that the patient was started on low weight heparin.The distributor stated that the patient's tests also indicated a thrombin generation potential of 1200 indicating a possible severe coagulation disorder.The distributor reported that the patient's tests indicated a ferritin value of 40.000.The distributor stated that a test of the patient's bone marrow indicated hemophagocytosis.The distributor reported that the patient was then diagnosed with hemophagocytic syndrome and immunoglobulins were administered to the patient in addition to steroids.The distributor stated that the immunoglobulins and steroids were ineffective, and the patient passed away on (b)(6) 2021 due to multiple organ failure.The distributor reported that the patient's medical staff stated that considering the temporal correlation, they believed that the patient's ecp treatment somehow triggered the patient's clinical condition.No product was returned for investigation.

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr as this incident was considered life threatening, the patient required hospitalization, and also due to the medical intervention of the lasix, diphenhydramine, diamorphine, oxygen, heparin, vasoactive drugs, steroids, and immunoglobulins 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 for investigation.The distributor handles all of the service for this device and maintains the device service history.Trends were reviewed for complaint categories, dyspnea, oxygen desaturation, pulmonary edema, tachycardia, shock, death, multiple organ failure, and hemophagocytic syndrome.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, low oxygen saturation, pulmonary edema, tachycardia, shock, multiple organ dysfunction syndrome, no code available: hemophagocytic syndrome.(b)(4).S.K.17-dec-2021.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; blanchardstown, dublin ; EI
• 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 ; shelbourne building; 53 frontage rd suite 300; hampton, NJ 08827
• MDR Report Key: 13026517
• MDR Text Key: 282420950
• Report Number: 2523595-2021-00112
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: (01)10705030100009(11)170426
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/17/2021

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: CELLEXUSA
• Device Catalogue Number: CELLEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2021
• Initial Date FDA Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2017
• 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): Death; Life Threatening; Required Intervention; Hospitalization
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 95 KG