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

Catalog Number 80360

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Date 06/17/2019

Event Type  Injury  

Manufacturer Narrative

Investigation: per the customer, the donor reports no known allergies.According to aabb technical manual 16th edition, adverse events seen at the time of donation or those reported later average about 3.5% of donations.Reactions that need medical care after the donor has left the donation site are seen in 1 in 3400 donors.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 following a platelet collection procedure on trima, a donor experienced a reaction.The donor experienced swelling around the eyes and mouth and the next day presented bruising around the needle site extending up to the donor's bicep.The donor visited her own physician due to the swelling and was prescribed prednisone, which caused the symptoms to subside.An ultrasound was performed on the donor's arm, which verified there was no deep vein thrombosis.Per the customer, there were no problems during the donation and the donor reported the next morning that she was feeling much better.Full donor id: (b)(6).The platelet collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide updated information in investigation:the run data file (rdf) was analyzed for this event.Per rdf analysis, the acratio was 11 for this procedure and was not changed.There was one alarm during theprocedure for a return pressure too high.There were minor adjustments made during therun, 1- draw down and 4-return down adjustments.The alarm did not return afteradjustments.There was nothing observed in the rdf that would indicate a citratereaction.The total amount of ac reported by the trima accel device was 188 ml with 159 mls tothe donor, 10 mls in rbc product 1 and 6 mls in rbc product 2.There were no events (alerts,adjustments, changes in pump speed, etc.) during the run that could have caused the reporteddonor reaction.The ac down button was pressed twice at 34.4 minutes, which decreased theac infusion rate to around 0.6 ml/min/ l tbv.There was no system or device malfunction identified that would indicate an issue with thetrima system or that the system contributed to the donor reaction.The system wasoperating as intended.Brusing around a needle site is a fairly common occurrence when having blood drawn ordonation procedures.Brusing usually appears because small blood vessels are accidentlydamaged.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide in corrected investigation: per rdf analysis, a 80360 tubing kit was loaded successfully andpassed the tubing set test.The ac ratio was 11 for this procedure and was not changed.Therewas one alarm during the procedure for a return pressure too high.There were minoradjustments made during the run, 1- draw down and 4-return down adjustments.The alarm didnot return after adjustments.There was nothing found in the rdf that would indicate a systemor device malfunction that would indicate an issue with the trima system or that the systemcontributed to the donor reaction.The system was operating as intended.Bruising around a needle site is a fairly common occurrence when having blood drawn or donationprocedures.Bruising usually appears because small blood vessels are accidently damaged.There was no system or device malfunction identified that would indicate an issue with the trimasystem or that the system contributed to the donor reaction.The system was operating asintended.Root cause: a definitive root cause for the patient's reaction could not be determined.Possible causes for the alleged citrate reaction include but are not limited to ac managementduring the procedure, the length of the procedure and/or patient sensitivity to anticoagulant orethylene oxide used to sterilize the disposable set.The bruising at the needle site could be associated with poor phlebotomy technique in associationwith difficult access or fragile vessels, and rapid return flows in some procedures can cause leakageof blood from the vessels into the surrounding tissue.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET + SAMPLER, PLASMA, AUTO RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8785722
• MDR Text Key: 150881823
• Report Number: 1722028-2019-00186
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583803602
• UDI-Public: 05020583803602
• Combination Product (y/n): N
• PMA/PMN Number: BK180231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Catalogue Number: 80360
• Device Lot Number: 1905012230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00058 YR
• Patient Weight: 72