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

Catalog Number CELLEX

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

Patient Problems Paralysis (1997); Ischemia Stroke (4418)

Event Date 01/09/2021

Event Type  Injury  

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 thrombolytic therapy 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 for investigation.A device service history review could not be performed as an instrument serial number was not provided within the complaint.Trends were reviewed for complaint categories, stroke and paralysis.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: ischemia stroke and paralysis (b)(4).

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced an ischemic stroke following an ecp treatment procedure.The customer stated that the patient underwent ecp treatment procedures on (b)(6) 2021 both of which were successfully completed and uneventful.The customer stated that on (b)(6) 2021, the patient went to the emergency department after experiencing right sided hemiplegia.The customer reported that the patient was admitted to the hospital on (b)(6) 2021 and an ischemic stroke was diagnosed through a ct scan and blood work.The customer stated that the patient underwent thrombolytic therapy while in the hospital; however, the customer was not able to provide any additional information regarding the patient's thrombolytic therapy.The customer reported that the patient's right sided hemiplegia resolved while in the hospital, and the patient was discharged from the hospital on (b)(6) 2021 with the medication kardegic.The customer stated that the patient's ecp treatment procedures were stopped following the patient's ischemic stroke, and were restarted two months after the patient's discharge from the hospital.The customer reported that there was no aggravation of the patient's chronic graft versus host disease (cgvhd) while the patient's ecp treatments were stopped.The customer stated that the patient continued with their ecp treatments until (b)(6) 2021.The customer reported that the patient was being treated with ecp for their cutaneous cgvhd, while the patient's oral and ocular cgvhd were being treated with topic treatments.The customer reported that after three weeks of ecp treatments, the patient experienced a marked improvement in both their cutaneous and oral cgvhd in the skull and face with a marked improvement in purplish pigmentation and discreet lichen in the mouth.The customer stated that there was no progression in the patient's ocular cgvhd.The customer reported that the patient's ciclosporin dosage, 50 mg x2 /day, was first decreased and then stopped six months after the initiation of the patient's ecp treatment procedures.The customer stated that when they ended the patient's ecp treatment procedures on (b)(6) 2021 only the patient's middle ocular cgvhd persisted which was being treated with a topic treatment.The customer reported that they were unsure if the patient's ecp treatments could have caused or contributed to the patient's ischemic stroke.The customer stated that it was possible that the patient's underlying conditions could have caused or contributed to the patient's ischemic stroke.The customer reported that the patient had the following comorbidities: arterial hypertension, sleep apnea, and a post traumatic subdural hematoma.No product was returned for investigation.

• 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: 12643827
• MDR Text Key: 276844274
• Report Number: 2523595-2021-00095
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/16/2021

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 Catalogue Number: CELLEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 10/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Life Threatening; Required Intervention
• Patient Age: 62 YR