MAUDE Adverse Event Report: THERAKOS INC. THERAKOS CELLEX

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Anemia (1706); Atrial Fibrillation (1729); Cardiopulmonary Arrest (1765); Death (1802); Hypoglycemia (1912); Hypoxia (1918); Internal Organ Perforation (1987); Seizures (2063); Thrombus (2101); Brain Injury (2219)

Event Type  Death  

Event Description

This is in response to an ecri alert for the therakos cellex.Ecri alert states that patients may be at increased risk for thromboembolism associated with treatment.On (b)(6) 2017 this patient received a chest ct with contrast, multiple thrombus found.Death summary: 57 aam with pmh multiple myeloma s/p allogenic stem cell transplant in 2008, chronic gvhd (biopsy proven lung, gi, skin involvement, on chronic immunosuppression) who was initially admitted (b)(6) after being found down and pea arrest with rosc.Underwent hypothermia protocol w/code event unfortunately subsequent mri c/w anoxic brain injury.Hospitalization c/b hypoglycemia, seizures (post-hypoxic myoclonic status epilepticus), hypoxic respiratory failure, pna s/p trach / peg, shock requiring vasopressors, aki 22 ischemic atn (not a dialysis candidate), gastric perforation (not a surgical candidate), mdr pna and vre bacteremia.Patient progressively decompensated over the past 10 days with off and on pressor requirement, frequent transfusions, afib with rvr, thrombocytopenia and anuric renal failure.On (b)(6) patient had pea arrest x 2 most likely 2/2 to hypoxia and anemia.After second code event family changed patient's code status to dnr with plan to discontinue any escalation of care.Patient remained on antibiotics and phenylephrine.At 1305 on (b)(6), i was called by nursing for the monitor reading asystole.Patient pronounced dead at 1307 and family was notified at bedside, they declined autopsy.

• Brand Name: THERAKOS CELLEX
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS INC. ; west chester PA 19380
• MDR Report Key: 7276095
• MDR Text Key: 100415434
• Report Number: MW5075281
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2018

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 57 YR
• Patient Weight: 77