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

Model Number 000000000000061000

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2014

Event Type  malfunction  

Event Description

The customer reported that on more than one occasion, during apheresis procedures, and while the patients/donors were connected, the data on the system screen disappeared.After some time, and smooth running of the procedures, the monitor re-appeared.All procedures were completed successfully, and no ill effects to the patients or medical interventions were necessary.Dates of occurrences as reported by the customer: (b)(6) 2013, (b)(6) 2014, (b)(6) 2014 due to eu data protection laws, the patient information is not available from the customer.This report is being filed in response to the customer filing a sae report with their local authorities.

Manufacturer Narrative

Investigation: the loss of the display view or loss of the ability to affect inputs on a touchscreen by the operator does not affect safety monitoring and mitigation's.This issue was trouble shot by a terumo bct technician at the customer site the next day after the first incident on (b)(6) 2013.A loose electrical connection from the display to the top cap circuit card assembly (cca) was found.The connection was secured at that time.The second report on (b)(6) 2014 was attributed to the same electrical connection that was loose when the machine was checked out after the customer initially reported it to terumo bct.The technician reseated the electrical connection at that time.The third report on (b)(6) 2014 was again attributed to poor electrical connection issues between the display and the top cap cca.The service technician replaced the top cap cca and the motherboard cca on (b)(6) 2014.There have not been any reports of the same issue since the service on (b)(6) 2014.Root cause: poor electrical connections between the display and the top cap cca caused the screen to go blank.A definitive cause of the loose connection remains undetermined at this time.Corrective action: an internal capa request has been initiated in regard to top cap cca issues.

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: kristen cohen ; 10811 w collins ave; lakewood, CO 80215 ; 3032052870
• MDR Report Key: 4347318
• MDR Text Key: 5204074
• Report Number: 1722028-2014-00496
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K071079
• 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
• Report Date: 11/24/2014

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: 000000000000061000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2014
• Initial Date FDA Received: 12/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2009
• 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