COBE SPECTRA LRS SYSTEM
Received Oct 22, 2015 · Event occurred Jul 23, 2015
Report 5167878 · MDR key 5167878
Device
Generic name
Separator, Automated, Blood Cell, Diagnostic
Manufacturer
Terumo Bct, IncModel number
02/M-069/89Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
60 YR
- Bradycardia
- Cardiopulmonary Arrest
- Death
- Vomiting
Narrative
Description of Event or Problem
PATIENT WITH SEVERE CARDIAC AMYLOIDOSIS UNDERWENT STEM CELL MOBILIZATION FOR PERIPHERAL BLOOD PROGENITOR CELL COLLECTION IN PREPARATION FOR AUTOLOGOUS STEM CELL TRANSPLANTATION. THE COLLECTION PROCEDURE WAS PERFORMED WITHOUT DEVIATIONS OR UNEXPECTED EVENTS; ON ARRIVAL HE COMPLAINED OF NAUSEA AND RECEIVED ONDANSETRON FOR THIS; HIS BLOOD PRESSURE DECREASED MODESTLY DURING THE PROCEDURE BUT REMAINED WITHIN THE PATIENT'S SELF-REPORTED USUAL RANGE; HE WAS EVALUATED BY THE MEDICAL DIRECTOR AND ADDITIONAL FLUID REPLACEMENT WAS INITIATED; HE REMAINED ASYMPTOMATIC WITH STABLE BLOOD PRESSURE. APPROXIMATELY TWO HOURS INTO THE COLLECTION PROCEDURE THE PATIENT ACUTELY DECOMPENSATED: HE SAT UP, VOMITED AND WENT INTO CARDIOPULMONARY ARREST. HE RECEIVED IMMEDIATE CPR, THE CODE TEAM ARRIVED AND WAS ABLE TO RESUSCITATE THE PATIENT FROM PEA (PULSELESS ELECTRICAL ACTIVITY) WITH BRADYCARDIA AND HE WAS TRANSFERRED TO THE MICU. SHORTLY AFTER TRANSFER, HE DEVELOPED BRADYCARDIA AND SUBSEQUENT CARDIOPULMONARY ARREST AGAIN. HE WAS NOT ABLE TO BE RESUSCITATED. THE CAUSE OF DEATH WAS ATTRIBUTED TO CARDIAC AMYLOIDOSIS.