MAUDE Adverse Event Report: TERUMO BCT, INC COBE SPECTRA LRS SYSTEM; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC

Model Number 02/M-069/89

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Cardiopulmonary Arrest (1765); Death (1802); Vomiting (2144)

Event Date 07/23/2015

Event Type  malfunction  

Event Description

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.

• Brand Name: COBE SPECTRA LRS SYSTEM
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): TERUMO BCT, INC; 10811 west collins ave.; lakewood CO 80215
• MDR Report Key: 5167878
• MDR Text Key: 28918150
• Report Number: 5167878
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2015,09/23/2015

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: Unknown
• Device Model Number: 02/M-069/89
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR