MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA COLLECT SET

Catalog Number 10116

Device Problems Decrease in Pressure (1490); Device Displays Incorrect Message (2591)

Patient Problems Reaction (2414); Irritability (2421)

Event Date 11/05/2015

Event Type  Injury  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a pediatric donor had a reaction at the end of a continuous mono nuclear cell (cmnc) collection procedure.During the procedure, the operator received multiple low pressure alarms.The operator stopped the procedure and disconnected the donor.While the operator was cleaning the donor's catheter connected to the jugular, the donor was observed to be very stressed and irritable then suddenly presented cardiopulmonary arrest.The donor was admitted to the emergency room (er) and required emergency attention.The customer stated that the donor recovered.Patient (donor) identifier is not available at this time.The disposable kit is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: per the customer, the nurse of the bone marrow transplant unit was permeabilizing the catheter due to a low flow extraction alarm and thus the patient was not connected to the spectra optia machine.It was at this time that the patient experienced the cardiopulmonary arrest incident with sustained bradycardia with consequent hypoxia due to high irritability, a stressful situation, intense crying, and spasm.The staff applied positive inpuventilation to recover the patient from bradycardia and the patient recovered after two minutes.The patient did not require adrenaline.The post-incident evaluation done by the customer determined that there was no evidence of hypocalcemia, hypovolemia, and the incident was not related to the spectra optia disposable set or machine.Review of the run data file (rdf) confirmed the occurrence of the ¿inlet pressure was too low¿ alarm nine times approximately one hour into the procedure.The alarms subsided after 20 minutes, when the operator indicated they cleaned the catheter.The alarms then recurred eight additional times approximately 2.5 hours into the procedure.Per the rdf, the operator appropriately adjusted the inlet flow rate in response to the alarms.The adjustments, and pausing to clean the catheter appeared to resolve the alarms temporarily, but the positioning of the catheter may have also contributed to the occurrence of the alarms.A review of the device history record for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: based on the procedural file analysis and the information provided by the customer, the donor reaction symptoms were due to the donor's physiology.The physician stated the adverse reaction and medical intervention were due to the patient¿s physiological response to high irritability and stressful situation.The doctor responsible for the procedure confirmed the incident is not related to the spectra optia disposable set.The procedural file analysis revealed no abnormalities in their performances.A definitive cause for the occurrence of the alarms during the procedure could not be determined.The most common source of pressure alarms is when the inlet flow rate is set too high for the given patient access, the patient access is occluded/ blocked, or the patient access is not properly positioned.The procedural file revealed no abnormalities in their performances.

Event Description

The customer declined to provide the patient's identifier.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5250910
• MDR Text Key: 32165824
• Report Number: 1722028-2015-00627
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2015

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: Health Professional
• Device Expiration Date: 06/01/2016
• Device Catalogue Number: 10116
• Device Lot Number: 06W3310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2015
• Initial Date FDA Received: 11/25/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/18/2015; 02/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 00023 MO
• Patient Weight: 14