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 Anemia (1706); Atrial Fibrillation (1729); Cardiac Arrest (1762); Death (1802); Hypoglycemia (1912); Hypoxia (1918); Unspecified Infection (1930); Internal Organ Perforation (1987); Pneumonia (2011); Seizures (2063); Shock (2072); Thrombosis (2100); Brain Injury (2219); Respiratory Failure (2484); No Information (3190)

Event Type  Death  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the patient's life threatening condition, the medical intervention that was provided to the patient, and the patient's death.This case is also 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 instrument's serial number was not provided, thus a device history review could not be performed.Trends were reviewed for complaint categories, thrombosis, cardiac arrest, other adverse event: anoxic brain injury, other adverse event: hypoglycemia, seizures, other adverse event: respiratory failure, pneumonia, other adverse event: shock, other adverse event: kidney injury/failure, other adverse event: gastric perforation, infection, other adverse event: atrial fibrillation, other adverse event: thrombocytopenia, anemia, other adverse event: hypoxia, and death.No trends were detected for these complaint categories.The assessment is based on information available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Adverse event terms: thrombosis, cardiac arrest, brain injury, hypoglycemia, seizures, respiratory failure, pneumonia, shock, other: kidney injury/failure, other: thrombocytopenia, organ(s), perforation of, infection, atrial fibrillation, anemia, hypoxia, and death.(b)(4).

Event Description

A facility medwatch report was received which stated that an extracorporeal photopheresis (ecp) patient had passed.The facility medwatch reported that in 2017, a patient received a chest ct with contrast and multiple thromboses were found.The patient was initially admitted to the hospital after being found down due to pulseless electrical activity arrest with return of spontaneous circulation.The patient underwent hypothermia protocol with this code event but unfortunately, a subsequent mri was consistent with anoxic brain injury.The patient's hospitalization was complicated by hypoglycemia, seizures (post-hypoxic myoclonic status epilepticus), hypoxic respiratory failure, pneumonia status post a tracheostomy and a feeding tube, shock requiring vasopressors, acute kidney injury 22, ischemic acute tubular necrosis (not a dialysis candidate), gastric perforation (not a surgical candidate), multi drug resistant pneumonia and vancomycin-resistant enterococci bacteremia.The patient progressively decompensated within ten days with off and on vasopressor requirement, frequent transfusions, atrial fibrillation with rapid ventricular rate/response, thrombocytopenia, and anuric renal failure.The patient experienced two more pulseless electrical activity arrests most likely due to hypoxia and anemia.After the second code event, the family changed the patient's code status to do-not-resuscitate with the plan to discontinue any escalation of care.The patient remained on antibiotics and phenylephrine.The doctor was called by the nursing staff to monitor the reading of asystole (cardiac flat line), and the patient was pronounced dead.The family was notified at the patient's bedside and they declined an autopsy.The patient's date of hospitalization was not provided nor was the patient's date of death.There was no mention of the patient's ecp treatments within the complaint.In addition, the instrument's serial number was also not available.Since the reporter's name and contact information were not provided, an additional follow-up regarding the patient's ecp treatments could not be performed.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: 7367868
• MDR Text Key: 103395692
• Report Number: 2523595-2018-00047
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2018

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: Nurse
• 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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/23/2018
• 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): Death; Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 57 YR