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

Model Number 82446

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

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

Event Date 05/05/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation: a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Correction: tbct clinical support offered retraining to the customer.Clinical support also provided instructions for raising the cassette manually to clear alarm (32785) system test failure - detected invalid state transition.Raising the cassette tray resolved the alarm issue.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that they tried to load a set and noticed that the platelet pump was in the wrong location.She corrected the pump location and performed the venipuncture before the cassette was lowered and primed.She then collected the blood samples and but, was unable to lower the cassette do to alarms.She then removed the set from the trima with the needle in the donors arm and loaded the set on a different trima.She was unable to continue because the needle clotted off.There were no ill affects to the donor and no medical intervention was required.Full patient id: (b)(6).The customer was unable to provide the donor's age/date of birth.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Correction: tbct clinical support offered retraining to the customer on may 5th.The customer declined the offer of retraining stating they were reviewing the issue with their staff internally and would reach out if any assistance was needed.They did not contact terumo bct for further assistance on retraining clinical support also provided instructions for raising the cassette manually to clear alarm (32785) system test failure - detected invalid state transition.Raising the cassette tray resolved the alarm issue.Root cause: a root cause assessment was performed for this complaint.Based on the available information, the root cause of the potential of air to donor was due to an operator error where they connected the donor too soon and before lowering and priming the set.

Event Description

The customer reported that they tried to load a set and noticed that the platelet pump was in the wrong location.She corrected the pump location and performed the venipuncture before the cassette was lowered and primed.She then collected the blood samples and but, was unable to lower the cassette do to alarms.She then removed the set from the trima with the needle in the donors arm and loaded the set on a different trima.She was unable to continue because the needle clotted off.There were no ill affects to the donor and no medical intervention was required.Full patient id: (b)(6).The customer declined to provide the donor's age.The collection set is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA PLATELET+SAMPLER, 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: 17005361
• MDR Text Key: 316022942
• Report Number: 1722028-2023-00190
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824461
• UDI-Public: 05020583824461
• 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: 05/25/2023

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: 82446
• Device Catalogue Number: 5824462
• Device Lot Number: 2212054251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 10/13/2023
• Supplement Dates FDA Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/02/2022
• 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 Sex: Male