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 Stroke/CVA (1770); Discomfort (2330); Malaise (2359); Numbness (2415)

Event Date 06/12/2019

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 rehabilitation.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 06-december-2017.As part of the review, it was determined that the instrument's last service prior to the event was on 05-june-2019.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, malaise, discomfort, cerebrovascular accident: stroke, and numb.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: malaise, discomfort, cerebrovascular accident, and numbness.(b)(4).

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced malaise, discomfort, numbness, and a cerebrovascular accident (stroke) following a treatment procedure.The customer stated that the patient experienced the stroke 12-16 hours after the successful completion of his ecp treatment procedure.The customer reported that the patient's ecp treatment procedure used heparin as the anticoagulant at a 10:1 ratio and this treatment was successfully completed with both blood and treated cells returned to the patient.The customer stated that there were no alarms during the patient's ecp treatment procedure and no clotting was observed in the kit.The customer reported that the patient was asymptomatic after the completion of their ecp treatment procedure and the patient had no complaints regarding not feeling well either before or after the procedure thus the patient was discharged home.The customer stated that 12-16 hours after the patient's ecp treatment procedure, the patient started to not feel well while he was at home.The customer reported that the patient felt discomfort on one side of his body.The patient stated that he had woken in order to use the bathroom, and that he was fine when he walked back to his bed from the bathroom but then it started.The patient reported that his face went numb among other symptoms so he called 911.The patient stated that he was then admitted to the hospital nearest his home.The patient reported that a ct scan was performed while he was in the hospital that showed a "clot in his head".The customer stated that the patient was then transferred to their hospital on (b)(6) 2019, since according to the patient his previous hospital felt that he would get better care where his specialty doctors were located.The customer reported that the patient was officially diagnosed with a stroke on (b)(6) 2019.The customer stated that he had no idea regarding the medical intervention that was performed at the patient's previous hospital.The customer reported that he was also not aware of the medical treatment that was provided to the patient while the patient was at his hospital as a different department (neurology services) was caring for the patient.The customer stated that the patient was stable and was awaiting placement at a rehab center, which did not currently have an open bed.On (b)(6) 2019, the patient reported that he was being discharged from the hospital that day and it was decided that he would be doing in home rehab.The patient stated that a nurse would come to his home 2-3 times a week for his rehab.The patient reported that it was going to be hard but he felt confident.The customer stated that patient's ecp treatment procedures are currently on hold while the patient recovers.The customer reported that the patient's stroke might have been caused by his ecp treatment procedures; however, currently his doctors are not sure what may have caused the patient's stroke.No product 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: 8801030
• MDR Text Key: 151421094
• Report Number: 2523595-2019-00085
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: (01)10705030100009(11)170606
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/17/2019

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2019
• Initial Date FDA Received: 07/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2017
• 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: 49 YR
• Patient Weight: 107