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

Model Number	81000
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process, a follow-up report will be provided.
Event or Problem 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.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.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: 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 further issues related to the reported condition identified.The service representative was able to duplicate the reported condition and noted the iv pole was not fully seated into the anti rotational bar and the bottom screw attaching the pole to the machine was missing.The service representative replaced the iv pole bearing sleeve as per manufacture's specifications and fully reseated the pole into the anti rotational block.Then verified the iv pole did not spin 360 degrees.Then performed and passed a full system auto test.Lastly, also conducted a visual inspection finding no other issues.Correction: a field service engineer adjusted the iv pole release button.Investigation is in process, a follow-up report will be provided.
Event or Problem 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.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.
Event or Problem 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.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.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: 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 further issues related to the reported condition identified.The service representative was able to duplicate the reported condition and noted the iv pole was not fully seated into the anti rotational bar and the bottom screw attaching the pole to the machine was missing.The service representative replaced the iv pole bearing sleeve as per manufacture's specifications and fully reseated the pole into the anti rotational block.Then verified the iv pole did not spin 360 degrees.Then performed and passed a full system auto test.Lastly, also conducted a visual inspection finding no other issues.Correction: a field service engineer adjusted the iv pole release button.Further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.It was confirmed that there was no injury or allegation of the iv pole falling.No further reporting will be provided as this does not represent a reportable event. .

• Brand Name: TRIMA ACCEL
• Common Device Name: 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: 19942755
• Report Number: 1722028-2024-00330
• Device Sequence Number: 4929328
• Product Code: GKT
• UDI-Device Identifier: 05020583810006
• UDI-Public: 05020583810006
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BK150321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2024

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
• Operator of Device: Health Professional
• Device Model Number: 81000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 10/10/2024; 10/10/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 10/17/2024; 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown