MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Catalog Number CELLEX

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

Patient Problem Thrombosis (2100)

Event Date 12/18/2019

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 lovenox that was provided to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.A device service history review could not be performed as an instrument serial number was not provided.Trends were reviewed for complaint category, thrombosis.No trends were detected for this complaint category.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: thrombosis.(b)(4).

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced a deep vein thrombosis (dvt) following a treatment procedure.The customer stated that the patient had received their ecp treatments from (b)(6) 2019 to (b)(6) 2020 for chronic graft versus host disease.The customer reported that the patient was diagnosed with a right lower extremity dvt on (b)(6) 2019.The customer stated that the patient was being treated with lovenox, 80 mg, bid for their dvt.The customer reported that the patient continued with their ecp treatments after their dvt diagnosis with their last ecp treatment on (b)(6) 2020.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: 10117240
• MDR Text Key: 199077352
• Report Number: 2523595-2020-00068
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/03/2020

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 Catalogue Number: CELLEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2020
• Initial Date FDA Received: 06/03/2020
• 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
• Patient Age: 74 YR