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); Dyspnea (1816); Neck Pain (2433); No Code Available (3191)

Event Date 02/23/2019

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the patient's hospitalization and the medical intervention of the cexane 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.An instrument serial number was not provided.The distributor has their own biomed who performs all of the service for their instruments.Trends were reviewed for complaint categories, pulmonary embolism, pain, shortness of breath, and cough.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, neck pain, dyspneas, and other: cough.(b)(4).

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced a pulmonary embolism, neck pain, dyspnea, and cough following a treatment procedure.The customer stated that the patient underwent an ecp treatment procedure on (b)(6) 2019 using a port access with acda as the anticoagulant at a 10:1 ratio.The customer reported that the patient had a mild asthma like wheeze when he arrived at their unit.The customer stated that the patient remained afebrile and was stable throughout their ecp treatment procedure.The customer reported that the patient developed neck pain, dyspnea and a cough on (b)(6) 2019.The customer stated that the patient returned to the hospital on (b)(6) 2019 where a ct pulmonary angiography was performed, which confirmed a pulmonary embolism.The customer reported that an electrocardiogram was also performed as well as a complete blood exam.The customer stated that the patient was started on clexane 80mg sc twice a day.The customer reported that the patient was managed as an outpatient and the patient returned the following day, (b)(6) 2019, for a follow-up visit.The customer stated that the patient was discharged with clexane 80mg sc twice a day and is still taking the medication.The customer reported that the patient's ecp treatment procedures were postponed for ten days.The customer stated that the patient's ecp treatment procedures recommenced on (b)(6) 2019.The customer reported that the patient has now successfully completed four additional ecp treatments procedures.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: 8511864
• MDR Text Key: 141916429
• Report Number: 2523595-2019-00057
• 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
• 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; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 81