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

Model Number 61000

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: a terumo bct service technician checked out the machine at the customer site and was able to duplicate the reported condition.Upon inspection, it was found that constant fluid was being detected.The technician reseated the connectors to upper strobe cca and to pcap cca without effect.The technician found no 24 vdc at upper strobe cca, but did at lower strobe cca.24vdc in sts was verified and fluid intrusion was found on the top cap cca.The top cap cca was replaced and verified per manufacturers instructions.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a dry load of a set, they received a "return line air detector detected fluid too soon" alarm.The operator attempted loading 2 additional dry sets but continued to receive the alarm.No patient (donor) was connected at the time of the event, therefore, no patient (donor) information is reasonably known.

Manufacturer Narrative

This report is being filed to provide additional information.Additional investigation: the design file and service history were reviewed for this device and there were no manufacturing or field issues related to the reported condition identified.

Manufacturer Narrative

This report is being filed to provide additional information in.Investigation: the run data file (rdf) was analyzed for this event.The rdf confirmed "return line air detector detected fluid too soon" occurred during the testing of a dry disposable set.The device was not connected to a patient at that time.Run data analysis of the previous run, shows the last known state of the rlad was 'fluid', indicating a failure of the air to donor safety mitigation system.Root cause: the root cause of this failure was a fluid spill on the device that leaked onto the top cap cca.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a spectra optia top cap cca was returned to terumo bct for investigation.The terumo bct technician was able to duplicate the reported condition.Upon visual inspection, precipitate was found on j2 and jumper p12 due to fluid leak.The service technician installed the top cap cca in an optia test bed, powered up and no problem occurred.He utilized sts 3.6 to perform rlad functional test and found that rlad detected fluid at all times and failed functional test.The dmm measurement showed no 24vdc (from j4-53 on top cap cca) to top user strobed river cca.On the top cap cca, no connection was found between p11-3(+24v_taos) to j4 pin 53.The pad was found to be damaged due to the spill.It was confirmed that top cap cca was defective due to spill.The device serial number history report indicates no further related issues have been reported for this device.Investigation is in-process.A follow-up report will be provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7583071
• MDR Text Key: 110875818
• Report Number: 1722028-2018-00161
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK160116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 61000
• Other Device ID Number: 05020583610002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/17/2018
• Initial Date FDA Received: 06/08/2018
• Supplement Dates Manufacturer Received: 06/11/2018; 07/19/2018; 08/02/2018
• Supplement Dates FDA Received: 07/03/2018; 07/27/2018; 08/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2017
• 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