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

Model Number 81000

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

Patient Problem No Patient Involvement (2645)

Event Date 06/14/2019

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 same day the issue was reported.Upon inspection, the technician found that the iv pole was dropping without being pressed due to there lease latch engaging the iv pole lever.The release latch was adjusted to only release the iv pole when the external button is pressed.The iv pole, iv pole latch, and the iv pole lever were verified to be functioning properly.The service technician completed the semi- annual maintenance per manufacturer specifications and the iv pole collar installation occured on 10/26/2018.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 30 has been initiated to notify all trima 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 has been completed to address this issue.Root cause: the root cause of this failure was a mis-aligned release latch on the iv pole.

Event Description

The customer reported that the iv pole on the trima device does not stay in the upright position when fluid bags are on hung on the pole.Per the customer, the pole is not dropping unexpectedly.The customer also stated that the iv pole collar was not on the machine at the time of use and confirmed there had been no injuries.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 Contact: steve kern ; 10810 w collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 8745725
• MDR Text Key: 164661558
• Report Number: 1722028-2019-00161
• 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: BK080058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 06/28/2019

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: 81000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/14/2019
• Initial Date FDA Received: 06/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2009
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other