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

Model Number 000000000000061000

Device Problem False Reading From Device Non-Compliance (1228)

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

Event Date 05/20/2014

Event Type  malfunction  

Event Description

The customer reported that during an allogeneic mononuclear cell (mnc) collection procedure,the total blood volume processed reading, ac infusion rate reading, and the ac to donor reading by the machine were incorrect.Per eu personal privacy protection laws, the patient information is not available from the customer.This report is being filed due to a device malfunction that has the potential for injury if it were to recur.

Manufacturer Narrative

Investigation: per the customer, after the collection of the 1st chamber (which took more than 4600 ml tbv), the collection valve wasn¿t closed ¿ plasma still flowed in to the collection bag, diluting the product.For the second chamber, the collection status screen showed processed tbv starting from around -4600ml and counting toward zero.The procedure was terminated and continued successfully on a different machine.Per the customer, the ac infusion rate was displayed as more than 53, and after the procedure was ended, the report screen showed that 12 ml of acda went to the donor, when was actually more than 500ml of ac.Moreover, tbv calculations were also not correct.Per the customer, the optia worked properly without any issues the prior day.The run data file (rdf) was analyzed for this event.Rdf review confirmed that the run was terminated and that safety never stopped monitoring as designed.Per terumo bct i&d, this is a software anomaly.The symptoms of the reported condition were reproduced in-house.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: a terumo bct service technician successfully completed a preventative maintenance (pm) the day before the incident.The following day, terumo bct service technician re-inspected the parameters and rebooted the device.An auto test was successfully performed.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: a query of all run data files on the network showed that this failure was the first occurrence of this software problem.The service history of this machine, for the past year was evaluated and there was no previous service that could reasonably contribute to the reported condition.Root cause: software defect correction: this issue was added to the internal issue tracking system for investigation of possible future software revisions.The device was replaced with another spectra optia.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: kristen cohen ; 10811 w collins avenue; lakewood, CO 80215 ; 3032052870
• MDR Report Key: 3885024
• MDR Text Key: 4653324
• Report Number: 1722028-2014-00242
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K071079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 000000000000061000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2009
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other