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

Model Number 81000

Device Problems Inadequate User Interface (2958); Adverse Event Without Identified Device or Use Problem (2993); Data Problem (3196); Patient Data Problem (3197)

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

Event Date 04/04/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer stated that the first shift operator entered data for a potential female donor.Once the operator entered the female donor information into the trima display screen, the donor did not qualify for a collection procedure.The second shift operator,inadvertently did not clear the previous donor information, instead, the second shift operator connected the male donor and began a collection procedure.The customer stated that the operator did not connect the anticoagulant (ac) during the collection procedure.An internal report shows that the machine has been in use with no further occurrences of the problem.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported an incident of data input error in the trima system.A collection procedure was being performed on a male, but the gender was entered as female in the system.The operator stopped and disconnected the donor from the procedure.The customer declined to provide patient (donor) identifier.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Rdf analysis showed the donor information was entered using the female donor's information.The operator then adjusted the donor hematocrit, platelet precount, and height over the next few minutes.Approximately 10 minutes later, the donor information was changed for a final time before the tubing set load to the information for the correct, male donor.Rdf analysis also showed that a tubing set was selected, but was not lowered onto the machine until approximately 15 minutes later.The tubing set did not pass the tubing set test and alerted the operator to a ¿pressure test failure¿ 5 times.Following the last alert, the operator chose to unload the tubing set.Based on the available information from the complaint description, it was reported that anticoagulant was not connected, however, the donor was connected in a stage where a donor should not have been and blood was noted to be in the tubing set.Root cause: the root cause of this failure was operator error.

Manufacturer Narrative

This report is being filed to correct information.

Manufacturer Narrative

This report is being filed to provide additional information.Additional investigation: one year of service history was reviewed for this device with no problems identified related to the reported condition.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.The customer alleged that the donor's information was not updated prior to the start of the procedure for a male donor.Review of the rdf analysis showed the donor information was entered using the female donor's information and the operator made adjustments to the donor hematocrit, platelet precount, and height over the next few minutes.Approximately 10 minutes later, the operator correctly entered the male donor's information for a final time before the tubing set load.Updated root cause: per the rdf analysis, no data entry error occurred.

• 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: 6528666
• MDR Text Key: 74074376
• Report Number: 1722028-2017-00160
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: BK120017
• 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: 04/27/2017

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: 04/05/2017
• Initial Date FDA Received: 04/27/2017
• Supplement Dates Manufacturer Received: Not provided; 06/15/2017; 08/10/2017
• Supplement Dates FDA Received: 05/17/2017; 06/30/2017; 08/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2012
• 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: 00032 YR
• Patient Weight: 78