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

Model Number 61000

Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384); Device Slipped (1584)

Patient Problem No Patient Involvement (2645)

Event Date 07/10/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: a terumo bct service technician checked out the machine at the customer site and adjusted the iv pole lock and completed the preventive maintenance on the device.The device serial number history report indicates no further related issues have been reported for this device.One year of service history was reviewed for this device with no other problems identified related to the reported condition.Correction: trima field action 28 has been initiated to notify all optia users to use precaution while transporting the device and a caution statement was included in the operator's manual.Corrective action: an internal capa has been initiated to evaluate reports of the iv pole dropping down suddenly.Implementation of the addition of a collar for the currently field installed devices will be completed to address this issue.Investigation is in process.A follow-up report will be provided.

Event Description

During preventive maintenance service at the customers site, the terumo bct service technician noticed the iv pole lock was loose.The iv pole slowly descends.No injury was reported for this incident and no patient was connected at the time the iv pole was sliding down, therefore no patient information is reasonably known.

Manufacturer Narrative

This report is being filed to provide in root cause: the root cause of this failure was the adjustment of the iv pole lock.

Event Description

No injury occured for this event to user or donor and no medical intervention was required.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8855184
• MDR Text Key: 165018295
• Report Number: 1722028-2019-00213
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583610002
• UDI-Public: 05020583610002
• Combination Product (y/n): N
• PMA/PMN Number: K172590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 08/02/2019

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
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/10/2019
• Initial Date FDA Received: 08/02/2019
• Supplement Dates Manufacturer Received: 08/09/2019
• Supplement Dates FDA Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other