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

Catalog Number 4824062

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2024

Event Type  malfunction  

Event Description

The customer reported that they entered in the incorrect donor information during a double platelet collection procedure.Per the customer, the donor was entered as 6'9 when the actual donor height was 5'9.Full donor id (b)(6) the donor is reported as "ok".The platelet collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: final fluid balance calculation equaled 100%.Based on the given information, the calculate blood donation volume was found to be 10% of the donor's tbv, which does not exceed the limit for 'maximum donation volume is 15% of the donor's tbv' for procedure qualification outlined in the operator's manual.Run data file (rdf) analysis indicates that there are portions of the procedure where the actual ac infusion rate (calculated by adjusting the infusion rate reported in the dlogs by the ratio between the entered and actual tbv's) exceeds 1.2 ml/min/l tbv.Excluding the initialization value, which is set high prior to the start of the first return and does reflect a true physical value, the highest the adjusted ac infusion rate reaches is 1.27 ml/min/l tbv, which occurred during a recovery state.Investigation is in process, a follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.11.Investigation: final fluid balance calculation equaled 100%.Based on the given information, the calculate blood donation volume was found to be 10% of the donor's tbv, which does not exceed the limit for 'maximum donation volume is 15% of the donor's tbv' for procedure qualification outlined in the operator's manual.Run data file (rdf) analysis indicates that there are portions of the procedure where the actual ac infusion rate (calculated by adjusting the infusion rate reported in the dlogs by the ratio between the entered and actual tbv's) exceeds 1.2 ml/min/l tbv.Excluding the initialization value, which is set high prior to the start of the first return and does reflect a true physical value, the highest the adjusted ac infusion rate reaches is 1.27 ml/min/l tbv, which occurred during a recovery state.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that they entered in the incorrect donor information during a double platelet collection procedure.Per the customer, the donor was entered as 6'9 when the actual donor height was 5'9.Full donor id - (b)(6) the donor is reported as "ok".The platelet collection set is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 18866433
• MDR Text Key: 337293012
• Report Number: 1722028-2024-00075
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824065
• UDI-Public: 05020583824065
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4824062
• Device Lot Number: 2302162142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/16/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Male