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

Catalog Number 10110

Device Problem Insufficient Information (3190)

Patient Problems Hyperventilation (1910); Collapse (2416)

Event Date 12/28/2013

Event Type  Injury  

Event Description

The customer reported that during a collection procedure, the donor collapsed and experienced hyperventilation.Per the customer, the donor needed some medical intervention.Patient information is not available at this time.The disposable set is unavailable for return because the customer discarded it.This report is being filed due to unspecified medical intervention.

Manufacturer Narrative

Investigation evaluation and corrective actions are in-process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: per the customer, during the procedure, the ac ratio was adjusted to account for clumping seen in the reservoir and the donor's sensitivity to citrate.After the reaction, the donor received a c++ infusion.The donor had no significant medical history in regards to this reaction.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.A review of the lot for similar reports was carried out, none have been reported.Root cause: this disposable set was unavailable for specific root cause analysis.Based on the customer's description and the data files, the donor experienced an ac reaction.There were no signals in the data files that indicate that a fault of the machine or disposable kit contributed to the donor reaction.There were several adjustments in the inlet flow rate that extended the procedure time in both runs.The ac infusion rates, which are the main culprit in ac reactions,were well within normal ranges.Some patients are more sensitive to citrate reactions, and require special attention.The spectra optia system has many safety features.However, a patient reaction can occur rapidly.Therefore, it is imperative that the operator monitor the patient and the system throughout the procedure.

Event Description

The customer declined to provide the patient identifier.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs, per fda request, to identify records in which a serious injury or medical intervention occurred, but the type of reportable event was not indicated as a serious injury in the mdr form.This supplement is being filed to modify information, per fda request.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 3591184
• MDR Text Key: 4140705
• Report Number: 1722028-2014-00019
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: SG
• PMA/PMN Number: BK120076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2015
• Device Catalogue Number: 10110
• Device Lot Number: 07V3129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2013
• 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: 00017 YR
• Patient Weight: 67