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 Pulmonary Embolism (1498); Chest Pain (1776); Dyspnea (1816)

Event Date 03/12/2019

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the patient's hospitalization.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.The distributor has their own biomed who performs all of the service for this instrument.Trends were reviewed for complaint categories, pulmonary embolism, chest pain, and shortness of breath.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: pulmonary embolism, chest pain, and dyspnea.(b)(4).S.K.(b)(6) 2019.

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced a pulmonary embolism (pe) following a treatment procedure.The customer stated that the patient underwent a successful ecp treatment procedure using a peripheral access with acda as the anticoagulant at a 10:1 ratio on (b)(6) 2019.The customer reported that there were no alarms during this treatment procedure.The customer stated that the patient was stable throughout the treatment procedure and the patient's observations were within normal limits.The customer reported that the patient was well upon discharge post ecp.The customer stated that the patient was admitted eight days later on (b)(6) 2019 to another hospital.The customer reported that they did not have access to the patient's medical records as the patient was being treated at a different hospital, but they were informed that the patient was admitted for chest pain and shortness of breath.The customer reported that they were also informed that a ct pulmonary angiography confirmed a pulmonary embolism.The customer stated that they did not know if any medical intervention was provided to the patient since the patient was at a different hospital, though they did know that the patient was still in the hospital.The customer reported that despite the patient's pe, the patient's ecp treatment procedures had been improving the patient's lung function.The customer stated that the patient had not received any further treatment currently, but they intended to recommence the patient's ecp treatment procedures, possibly next week.The customer reported that it was unclear if the patient's ecp treatments procedures could have contributed to the patient's pe.However, the customer stated that it was possible that the patient's underlying condition may have contributed to their pe.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: 8510184
• MDR Text Key: 141792544
• Report Number: 2523595-2019-00053
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/12/2019

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: 03/13/2019
• Initial Date FDA Received: 04/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2012
• 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
• Patient Age: 69 YR
• Patient Weight: 93