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

Model Number 917000000

Device Problems Unintended System Motion (1430); Defective Component (2292); Unintended Movement (3026)

Patient Problem No Patient Involvement (2645)

Event Date 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

During a service call at the customer¿s site, the terumo bct service technician discovered the iv pole on the trima equipment would not stay up.The service technician adjusted iv polelocking system.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

This report is being filed to provide additional information.Investigation: the terumo bct service representative confirmed the reported condition at the customer site.The locking system was adjusted.One year of service history was reviewed for this device with no other problems identified related to the reported condition.The device serial number history report indicates no further related issues have been reported for this device.Correction: trima field action 30 has been initiated and provides for the installation of an iv pole collar to the iv pole to mitigate potential injury.A review of the device history record confirms the device had the iv pole collar installed prior to this occurrence.The customer did not incur or allege any injuries from the falling iv pole.Corrective action: an internal capa has been initiated to evaluate reports of the iv pole dropping down suddenly.Root cause: the root cause of this failure was a misaligned locking system on the iv pole.

• 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: 8033554
• MDR Text Key: 128199787
• Report Number: 1722028-2018-00299
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: BK180231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 11/02/2018

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: 10/09/2018
• Initial Date FDA Received: 11/02/2018
• Supplement Dates Manufacturer Received: 11/27/2018
• Supplement Dates FDA Received: 11/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other