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

Model Number 81000

Device Problems Component Falling (1105); Device Slipped (1584)

Patient Problem No Patient Involvement (2645)

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

Additional method code: c91963 mechanical evaluationinvestigation: terumo bct's service technician successfully completed the preventativemainenance (pm) procedure per manufacturer's specification.The service technican was able to duplicate the reported condition of the iv pole.The iv pole release mechanism was adjusted.An autotest and saline run were successfully performed and the machine was returned to service.An internal report indicates that 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 relatedto the reported condition.Correction: trima field action 30 has been initiated to notify all trima users to use precautionwhile 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.Investigation is in process.A follow-up report will be provided.

Event Description

While a service technician was performing a preventative maintenance (pm) on a trima machine at the customer's site, it was noted that the iv pole would not stay in the 'up' positon.No injuries were reported and no patient or donor was connected at the time the iv pole was sliding down, therefore no patient or donor information is reasonably known.

Manufacturer Narrative

This report is being filed to provide additional information.The root cause was the adjustment of the iv pole release mechanism.

• 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: 7053310
• MDR Text Key: 93713369
• Report Number: 1722028-2017-00457
• 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: company representative
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/22/2017

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
• Other Device ID Number: 05020583810006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2017
• Initial Date FDA Received: 11/22/2017
• Supplement Dates Manufacturer Received: 12/13/2017
• Supplement Dates FDA Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2007
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other