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

Catalog Number 82406

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2019

Event Type  Injury  

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that post donation on a trima device, the donor presented with a hematoma a bit further up the arm than the venipuncture site.Per the customer, the procedure was carried out normally and only low extraction (draw) pressure alarms occured with instructions for the donor to open and close his hand.The procedure was ended with rinse back and no other issues presented.The donor did not present any pain or upset and the puncture point did not show any lesions.Minutes later, after the procedure end and the donor was disconnected, a hematoma presented and the donor was taken to the customer urgency department.He was evaluated by the angiology and vascular surgery department and discharged the same day.Per the customer, the donor status is "ok" and no surgery was needed.Patient id is not available at this time.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide in investigation: the run data file (rdf) was analyzed for this event.The trima system monitorsthe pressure signals in the inlet and return lines throughout the entirety of the procedure.Thesesignals will alert the operator to low draw pressure and high return pressure if the donor venousaccess is not adequate.Signals from the run data file showed sudden changes in pressure at eachof the ¿draw pressure too low¿ alerts, which indicates that the donor may have moved their armor the needle may have become unsecured, leading to slight donor injury.There is no evidence orsuspicion of device malfunction based on the run data file analysis.Root cause: a definitive root cause for the donor's hematoma could not be determined.Possible causes include but are not limited to:- poor phlebotomy technique- rapid return flows- unsecured needle, donor moved arm during procedure that compromised needle positionthere was no evidence or suspicion of device malfunction based on the run data file analysis.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8865002
• MDR Text Key: 153410077
• Report Number: 1722028-2019-00217
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824065
• UDI-Public: 05020583824065
• Combination Product (y/n): N
• PMA/PMN Number: BK180231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2021
• Device Catalogue Number: 82406
• Device Lot Number: 1901073130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00048 YR
• Patient Weight: 59