MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

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

Patient Problem Thrombosis (2100)

Event Date 03/06/2019

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 thrombectomy and lovenox 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 therefore, a device service history review was performed.The instrument has been located at the customer's site since 09-oct-2017.As part of the review, it was determined that the instrument's last service was on 26-feb-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 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.Mc (b)(4), 04/10/2019.

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced a bilateral deep vein thrombosis (dvt) following a treatment procedure.The customer stated that the patient's last ecp treatment procedure was on (b)(6) 2019 and this treatment used heparin as the anticoagulant at a 8:1 ratio.The customer reported that this ecp treatment procedure was successfully completed without any alarms or adverse events.The customer stated that the patient returned for their next ecp treatment procedure on (b)(6) 2019.However, the customer reported that they assessed the patient prior to starting their ecp treatment procedure due to the patient's complaints of hip pain and not feeling well.The customer stated that based on the patient's assessment, they decided to not perform the patient's ecp treatment procedure and instead the patient was admitted to the hospital on (b)(6) 2019 due to the patient's failure to thrive.The customer reported that during the patient's admission it was noted that the patient had swelling in both of her legs.The customer stated that an ultrasound was then performed which detected a dvt in both of the patient's legs.The customer reported that once the dvts were confirmed a thrombectomy was performed in order to remove the clots.The customer stated that the patient is currently on lovenox.The customer reported that the patient was still in the hospital due to failure to thrive.The customer stated that they could not rule out the patient's ecp treatment procedures as a possible contributor to the patient's dvts.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: 8502272
• MDR Text Key: 141580528
• Report Number: 2523595-2019-00052
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: (01)10705030100009(11)170411
• 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: 04/10/2019

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: 03/12/2019
• Initial Date FDA Received: 04/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2017
• 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): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 82