FDA Adverse Event Death Summary report: N

THERAKOS CELLEX

MDR report key: 7276095 · Received February 15, 2018

Report

Report Number
MW5075281
Event Type
Death
Date Received
February 15, 2018
Report Date
February 14, 2018
Manufacturer
THERAKOS INC.
Product Code
LNR
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
117462 THERAKOS CELLEX CELLEX LNR THERAKOS INC.

Patients

Seq Age Sex Outcome Treatment
1 57 YR Death