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

Model Number 81000

Device Problems Component Falling (1105); Loose or Intermittent Connection (1371)

Patient Problem No Patient Involvement (2645)

Event Date 08/10/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: a service call was placed and a terumo bct's service technician visually inspected the machine at the customer's site.Upon visual inspection, the service technician noted an anti-coagulant (ac) spill on the machine.The service technician cleaned the iv pole and found the iv pole slippery.It was observed that the iv pole stays in the 'up' position when it is extended, however, the iv pole slowly slides down.The service technician removed the side panels for visual inspection.The iv pole was also removed and cleaned with alcohol.The iv pole was assembled and a functional test was successfully performed.The machine was returned to service.Investigation is in processed.A follow-up report will be provided.

Event Description

The customer reported that the iv pole on the trima equipment would not stay up.Per the customer , the trima is being held in a extended position with co flex.No injury was reported for this incident and no patient was connected at the time the iv pole was falling down unexpectedly, therefore no patient information is reasonably known.

Manufacturer Narrative

This report is being filed to provide additional information and corrected information.Root cause: the root cause of this failure was residue left on the iv pole from cleaning the acs pill resulted in the iv pole being slippery.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: an internal report shows that the machine has been in use with no further occurrences of the problem.One year of service history was reviewed for this device with no problems identified related to the reported condition.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 not locking in place.

• 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: 6830295
• MDR Text Key: 84325586
• Report Number: 1722028-2017-00343
• 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: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2017

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: 08/10/2017
• Initial Date FDA Received: 08/30/2017
• Supplement Dates Manufacturer Received: 10/11/2017; 11/09/2017
• Supplement Dates FDA Received: 10/17/2017; 11/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2006
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other