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

Model Number 61000

Device Problems Defective Component (2292); Obstruction of Flow (2423)

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

Event Date 07/19/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: a terumo bct service technician checked out the machine at the customer site.Upon inspection, it was found that the rlad detector was defective.The detector was replaced, an autotest was performed that the system was verified as fully operational.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during prime on the spectra optia machine the return line air detector (rlad) alarmed seeing fluid when the disposables set was dry.Due to eu personal data protection laws, the patient (donor) information and outcome are not available from the customer.

Manufacturer Narrative

Investigation: the run data file was able to confirm the device failed safe with a 'return line air detector detected fluid too soon' alarm, therefore, the device had a fail safe alarm condition.One year of service history was reviewed for this device with no issues related to the reported condition identified, and no further related issues have been reported for this device.The investigation is in process, a follow-up report will be provided.

Manufacturer Narrative

This report is being submitted to provide additional information.Root cause: since the replacement of the referenced part(s) has resolved the issue, it is likely that this part was defective or a contributing factor.

• 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: 7773180
• MDR Text Key: 117272865
• Report Number: 1722028-2018-00214
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583610002
• UDI-Public: 05020583610002
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K153601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/10/2018

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 08/10/2018
• Supplement Dates Manufacturer Received: 08/31/2018; 09/27/2018
• Supplement Dates FDA Received: 09/05/2018; 09/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2014
• 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