MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM

Model Number 81000

Device Problems Mechanical Problem (1384); Mechanics Altered (2984)

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

Event Date 02/22/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation: a terumo bct service technician checked out the device at the customer site.The technician was able to duplicate the reported condition.The iv pole was falling down when hanging bag on the left side.They adjusted and aligned after confirming the iv pole would drop when the top of it was touched.The lock assembly for the iv pole latch was inspected and it was found that the latch assembly needed to be adjusted to make it operate per manufacture's specifications.The latch assembly was adjusted and tested and the machine was returned to service.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.Per the customer the iv pole clamp was installed.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

Investigation: a terumo bct service technician checked out the device at the customer site.The technician was able to duplicate the reported condition.The iv pole was falling down when hanging bag on the left side.They adjusted and aligned after confirming the iv pole would drop when the top of it was touched.The lock assembly for the iv pole latch was inspected and it was found that the latch assembly needed to be adjusted to make it operate per manufacture's specifications.The latch assembly was adjusted and tested and the machine was returned to service.An iv pole safety collar was installed prior to the reported incident.The device serial number history report indicates one further related issue that has been reported for this device.Overview: an investigation was conducted for the following incident description: iv pole falls down when hanging bag on the left side.Investigation details: no injuries were reported.An iv pole safety collar was installed prior to the reported incident.A service engineer visited the customer site and confirmed that the iv pole dropped when the top of the pole was touched.The lock assembly for the iv pole latch was inspected and it was found that the latch assembly needed to be adjusted to make it operate per specification.The service engineer readjusted the latch assembly and released the machine for service.Device serial number history: the device serial number history report indicates one further related issue that has been reported for this device.One year of service history was reviewed for this device with no issues related to the reported condition identified.Root cause investigation and conclusion: a root cause assessment was performed for this complaint.The root cause was determined to be the need for a latch assembly adjustment.Correction: the service engineer readjusted the latch assembly and released the machine for service.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be the need for a latch assembly adjustment.

Event Description

The customer reported that the iv pole on the trima equipment unexpectedly lowers down.Per the customer the iv pole clamp was installed.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.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL AUTOMATED BLOOD COLLECTION 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
• MDR Report Key: 13804252
• MDR Text Key: 293877924
• Report Number: 1722028-2022-00088
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583810006
• UDI-Public: 05020583810006
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/17/2022

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: 81000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/23/2022
• Initial Date FDA Received: 03/18/2022
• Supplement Dates Manufacturer Received: 08/10/2022
• Supplement Dates FDA Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2017
• 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