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

Model Number 81000

Device Problems Collapse (1099); Mechanical Problem (1384); Device Slipped (1584)

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

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation: a terumo bct service technician checked out the machine at the customer site and was able to confirm the reported condition.The technician adjusted iv pole button in side panel and also replaced centrifuge mounts.Investigation is in process.A follow-up report will be provided.

Event Description

Customer reported the iv pole does not stay up.(b)(6) 2021 10:19 am iv pole fall/collapse data.No patient information needed unless injury occurred.Event information: device serial number: (b)(4).Was an iv pole clamp installed: caller did not know o if no, was a clamp ever installed.: was there an injury: no o if yes: what is the status of the patient: subjects identifier/id: subjects age: subjects weight: subjects height: subjects gender: was there any medical intervention: no o if yes, describe the medical intervention and the name/title of who ordered it: request the following: service call (requested/reason if not required) o dispatch date and wo for installation of iv pole clamp:.

Manufacturer Narrative

This report is being filed to provide additional information in h.6.Investigation: a terumo bct service technician checked out the machine at the customer site and was able to confirm the reported condition.The technician adjusted iv pole button in side panel and also replaced centrifuge mounts.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.No adverse event occurred and no medical intervention was required.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.No adverse event occurred and no medical intervention was required.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 machine at the customer site and was able to confirm the reported condition.The technician adjusted iv pole button in side panel and also replaced centrifuge mounts.One year of service history was reviewed for this device with no issues related to the reported condition identified.Investigation is in process.A follow-up report will be provided.

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 and was able to confirm the reported condition.The technician adjusted iv pole button in side panel and also replaced centrifuge mounts.One year of service history was reviewed for this device with no issues related to the reported condition identified.The device serial number history report indicates no further related issues have been reported for this device.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be related to the loose iv pole button in the side panel.

Event Description

The customer reported that the iv pole on the trima equipment unexpectedly lowers down.No adverse event occurred and no medical intervention was required.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: 12308245
• MDR Text Key: 269224080
• Report Number: 1722028-2021-00262
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK040069
• 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,Followup,Followup
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2005
• 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