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

Model Number 81000

Device Problems Component Falling (1105); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2017

Event Type  malfunction  

Manufacturer Narrative

Additional method code: (b)(4).Maintenance review investigation: a service call was placed and a terumo bct service technician visually inspected the device at the customer site.The service technician was unable to duplicate the reported condition.Upon visual inspection, it was noted that the iv pole was locking and unlocking, raising and lowering correctly.The service technician proactively replaced the iv pole and performed a functional test on the iv pole.The iv pole is functioning per manufacturing specifications.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: 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.

Event Description

The customer reported that while an operator was cleaning and packaging the trima machine for a mobile drive, he was pressing the button to lower the iv pole, the pole fell down onto his thumb nail.Per the customer, the operator did not seek medical attention or treatment.The patient (operator) is reported in healthy stable condition.

Manufacturer Narrative

This report is being filed to provide addtional information.Investigation: an internal report shows that the machine has been in use with a similaroccurrence of the problem with an incident date of (b)(6) 2017 (reported on mdr#:1722028-2017-00459).Root cause: the root cause was the iv pole button was pressed by the operator and fell ontheir hand.

• 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: 6976669
• MDR Text Key: 91089949
• Report Number: 1722028-2017-00413
• 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
• Report Date: 10/25/2017

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: 10/03/2017
• Initial Date FDA Received: 10/25/2017
• Supplement Dates Manufacturer Received: 11/29/2017
• Supplement Dates FDA Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2006
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00052 YR
• Patient Weight: 113