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

Model Number 61000

Device Problems Mechanical Problem (1384); Device Slipped (1584); Material Twisted/Bent (2981); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation: a (b)(4) service technician checked out the machine at the customer site.It was found that the iv pole would not stay up & the handle bar in the back is bent.It was determined that the device is unrepairable and the shifting of the top cap which could indicate a damaged frame.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that the iv pole on the trima equipment unexpectedly lowers down.The iv pole won't stay up & the handle bar in the back is bent.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.

Event Description

The customer reported that the iv pole on the trima equipment unexpectedly lowers down.The iv pole won't stay up & the handle bar in the back is bent.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 additional information in h.6 and h.10.Investigation: a terumo bct service technician checked out the machine at the customer site.It was found that the iv pole would not stay up & the handle bar in the back is bent.It was determined that the device is unrepairable and the shifting of the top cap which could indicate a damaged frame.The device serial number history report indicates no further related issues have been reported for this device.The relevant customer-facing associate was sent a letter to notify them that the device has sustained significant damage and is not repairable under original manufacturer standards.The letter informed the associate that the device should not be returned to service due to the damage sustained.The associate was asked to contact the customer and explain that this device will not be repaired.Root cause: a root cause assessment was performed for this complaint.Based on the available information, the root cause of the frame damage and iv pole failure could not be determined, one possible cause relates to damage sustained at the customer site.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 12217469
• MDR Text Key: 266163274
• Report Number: 1722028-2021-00244
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583610002
• UDI-Public: 05020583610002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK120076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/23/2021

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
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/23/2021
• Supplement Dates Manufacturer Received: 10/13/2022
• Supplement Dates FDA Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other