MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Catalog Number CELLEX

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

Patient Problems Muscle Weakness (1967); Low Oxygen Saturation (2477); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/14/2020

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the medical intervention of the oxygen 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.A device service history review could not be performed as an instrument serial number was not provided.Trends were reviewed for complaint categories facial nerve paralysis, weakness, oxygen desaturation, and ambulation difficulties.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: muscle weakness, low oxygen saturation, ambulation difficulties, and no code available: facial nerve paralysis.(b)(4).

Event Description

While performing a reconciliation of the fda maude database on (b)(6) 2020, we could not find any evidence within our complaint database that user facility report mw5094184 had been reported to mallinckrodt by the reporter.A complaint was then opened in order to capture the information within this user facility report.The user facility report stated that an extracorporeal photopheresis (ecp) patient walked into the clinic in order to receive their ecp treatment procedure.The patient's vitals were at baseline when they arrived at the clinic.At end of the patient's ecp treatment procedure, the patient was unable to "sit self up out of bed" and the patient's oxygen saturation was noted to be in 60's.The patient's left arm appeared to be flaccid and the patient was unable to lift this arm.The patient also displayed notable weakness in their left leg and the patient was unable to smile.The patient was alert and oriented.The patient was administered higher concentrations of oxygen until their oxygen saturation returned to normal.The rapid response team was then called and the patient was transferred to the emergency room for a stroke alert workup.The user facility report stated that the smart card for this ecp treatment procedure was going to be returned for investigation; however, we could not find any evidence that this smart card was sent to mallinckrodt for investigation.All of the smart cards that have been received at mallinckrodt so far for the year have been reconciled with other existing complaints.The facility report stated that this adverse event occurred without identified device or use problem.As the user facility report did not contain either the name of the reporter or the name of reporter's facility, we are unable at this time to perform any follow-ups regarding this case.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: 10722899
• MDR Text Key: 213068982
• Report Number: 2523595-2020-00117
• Device Sequence Number: 1
• Product Code: LNR
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/22/2020

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: 09/23/2020
• Initial Date FDA Received: 10/22/2020
• 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): Required Intervention