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

Model Number 917000000

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 01/08/2018

Event Type  Injury  

Manufacturer Narrative

Investigation: a terumo bct service technician visually inspected the device at the customer site.An autotest was successfully performed.The service technician verified that all pressure detectors were functioning per manufacturer's specification.An autotest was successfully performed.Investigation is in-process.A follow-up report will be provided.

Event Description

The customer reported that during a trima donation procedure, the donor developed a hematoma.The operator stopped and disconnected the donor from the procedure.It is unknown at this time if the medical intervention was required for this event.Due to eu personal data protection laws, the patient (donor) information is not available from the customer.

Manufacturer Narrative

Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.During customer follow-up, the customer stated that the donor's hematoma was treated with a cold pack, skin ointment and rest.Therefore, the donor did not require medical intervention beyond first aid treatment.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 other problems identified related to the reported condition.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the run data file (rdf) was analyzed for this event.The trima system monitors the pressure signals in the inlet and return lines throughout the procedure.These signals will alert the operator to low draw pressure and high return pressure if the donor venous access is not adequate.If the procedure is running smoothly without alerts, but an access alert is suddenly generated, the donor may have moved their arm or the needle may have become unsecured, which may cause slight donor injury.Analysis of the run data file did not show any abnormal pressure signals.The ¿return pressure too high¿ alert generated just before the operator terminated the procedure appeared to be due to a true donor access related issue.The access pressure sensor and trima system appear to be functioning as designed.Root cause: the root cause of this failure is undetermined.

Manufacturer Narrative

This report is being filed to provide additional information and corrected information.Corrected investigation: during customer follow-up, the customer stated that the hematoma was treated with a cold pack, skin ointment, and the patient rested.A terumo bct service technician visually inspected the device at the customer site and was able to duplicate the reported condition with the pressure in the pumps.The service technician turned different pumps to release the pressure and was able to press 'continue' on the trima display screen.The service technician verified that all pressure detectors were functioning per manufacturer's specification.An autotest was successfully performed.The run data file (rdf) was analyzed for this event.The trima system monitors the pressure signals in the inlet and return lines throughout the entirety of the procedure.These signals will alert the operator to low draw pressure and high return pressure if the donor venous access is not adequate.If the procedure is running smoothly without alerts, but an access alert is suddenly generated, the donor may have moved their arm or the needle may have become unsecured, which may cause slight donor injury.Analysis of the run data file did not show any abnormal pressure signals.The ¿return pressure too high¿ alert generated just before the operator terminated the procedure appeared to be due to a true donor access related issue.There is no evidence or suspicion of device malfunction based on the rdf analysis.

Event Description

The customer reported that a donor developed a hematoma during a trima donation procedure.The operator stopped the procedure and the donor was disconnected.The customer stated that they followed the instructions prompted on the display screen of the trima machine, however, they were unable to press the 'continue' button because the pressure from the trima machine was incorrect.The customer declined to provide patient identifier and age.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSYEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7238122
• MDR Text Key: 98913008
• Report Number: 1722028-2018-00026
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: BK990025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 01/08/2018
• Initial Date FDA Received: 02/02/2018
• Supplement Dates Manufacturer Received: 03/27/2018; 05/02/2018; 05/18/2018
• Supplement Dates FDA Received: 04/13/2018; 05/08/2018; 05/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2001
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 72