MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA APHERESIS SYSTEM

Model Number 000000000000061000

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/05/2015

Event Type  Injury  

Event Description

The customer reported that they received a 'patient's fluid balance may be lower than reported' alarm on a spectra optia machine.It is not known at this time if medical intervention was required for this event.Due to (b)(6) personal data protection laws, the patient information is not available from the customer.This report is being filed due to insufficient information provided at this time to determine if a malfunction with the potential for death or injury occurred.

Manufacturer Narrative

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

Manufacturer Narrative

Investigation: the device is outside of the warranty period.The original lower level sensor was not available for return and investigation.An internal report indicates the customer has had additional fluid issues on this device that are within the specifications of pump accuracy.Root cause: undetermined.Correction: the device failed safe.

Manufacturer Narrative

Investigation: the machine was tested at the customer site.The low level sensor was replaced and the fluid balance was found to be ok.The service history for the past year was reviewed.There has been no previous service for the device that reasonably indicates a relation to the current reported condition.The run data file (rdf) was analyzed for this event.Signals in the rdf indicate that the fluid balance reported on the spectra optia system is -15ml and the patient's tbv is 4568ml.The worst-case fluid balance for the patient was calculated to be (b)(6) which is within our current tolerance of (b)(6).Investigation is in-process.A follow-up report will be provided.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs to identify records in which an event occurred, but the type of reportable event was not indicated.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 4471217
• MDR Text Key: 20750388
• Report Number: 1722028-2015-00035
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 01/05/2015

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 Model Number: 000000000000061000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2015
• Initial Date FDA Received: 01/30/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/24/2015; 04/08/2015; 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other