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

Model Number 917000000

Device Problem Component Falling (1105)

Patient Problem No Patient Involvement (2645)

Event Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

Maintenance review, investigation: the service technician visually inspected the machine at the customer's site and confirmed the reported condition.The technician found that the iv pole lever was slightly bent from inside the device.He straightened the iv pole lever and made slight adjustment to the iv pole set screw button present on the side panel of the machine and verified that iv pole is adjusted as per the manufacturer's specifications.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 problems identified related to the reported condition.Root cause: the root cause was the iv pole button set screw was out of alignment and the bent iv pole lever.Correction: a trima field action 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.

Event Description

The customer reported that the iv pole on the trima would not stay up.Per customer, no injuries occurred to the patient (donor) and operator was reported for this specific incident and therefore no patient (donor) or operator 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: 7488759
• MDR Text Key: 107593669
• Report Number: 1722028-2018-00119
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK010046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 05/04/2018

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: 917000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2003
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other