MAUDE Adverse Event Report: MALLINCKRODT HOSPITAL PRODUCTS, INC. (THERAKOS INC.) CELLEX; SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL

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

Patient Problems Chest Pain (1776); Respiratory Distress (2045); Thrombus (2101); Discomfort (2330); Neck Pain (2433)

Event Date 04/25/2019

Event Type  Injury  

Event Description

Patient arrived in apheresis area in good health to receive extracorporal photophoresis with the therakos cellex machine.The nurse drew blood for labs but drew a large clot from the lumen.Right after, the patient became visibly distressed.She complained of shortness of breath and started to cough.She complained of chest heaviness.A stat ekg was done, oxygen was applied and a registered respiratory therapist (rrt) was called.The patient was transported to the emergency department (ed).In the ed, via ultrasound a large intrajugular thrombus was diagnosed on ultrasound.Vq (ventilation-perfusion scan) high probability of pulmonary embolism (pe) and admission required.Patient reported neck discomfort during photopheresis and was asked to be seen for line assessment.Per patient, she has been experiencing discomfort on her right neck with motion, eating and swallowing.Symptoms started three days after the 8th treatment.A large clot was removed from the central line prior to procedure.Manufacturer response for extracorporeal photopheresis machine, cellex (per site reporter).Pending.

• Brand Name: CELLEX
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): MALLINCKRODT HOSPITAL PRODUCTS, INC. (THERAKOS INC.); 1425 us route 206; bedminster NJ 07921
• MDR Report Key: 8595820
• MDR Text Key: 144598158
• Report Number: 8595820
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/29/2019
• Device Age: 2 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 19710 DA