MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLATELET, PLASMA, RBC SET

Catalog Number 000000000000080400

Device Problems Air Leak (1008); Device Displays Incorrect Message (2591)

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

Event Date 07/07/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer, the phlebotomy was the cause of the air in the return line.The run data file (rdf) was analyzed for this event.The signals in the run data file do not indicate a conclusive cause for the air in the return line reported for this collection.Based on the available information, it is possible that the reported results as well as the ¿return pressure too high¿ alert ¿level sensor error¿ alerts and ¿centrifuge pressure too high¿ alert could have been caused by a kinked, occluded or clamped return line.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported they received multiple alarms, including 'return pressure too high' alarms, at the beginning of a platelet donation procedure.They determined the venipuncture was unsuccessful.The operator paused the procedure and sterile docked a new needle to the disposable set.After the 2nd venipuncture of the platelet donor, they noticed air in the return line.The operator clamped the return line and discontinued the procedure.Per the customer, they do not believe the donor received infusion of any air and the donor is reported in 'healthy' condition.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Root cause: the signals in the run data file (rdf) do not indicate a conclusive cause for the air in the return line reported for this collection.Possible root cause were provided in the initial report.Per the rdf, the system performed as designed by providing the appropriate alerts.

Event Description

No medical intervention was required for this event.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs to identify records in which an event occurred, but the type of reportable event was not indicated.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 5005169
• MDR Text Key: 23392410
• Report Number: 1722028-2015-00490
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK140180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 07/21/2015

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 Expiration Date: 05/01/2017
• Device Catalogue Number: 000000000000080400
• Device Lot Number: 05Y4108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2015
• 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 Age: 57 YR
• Patient Weight: 104