MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; ACCESSORY PLATELET BAG, ISBT

Catalog Number	70030
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number, manufacture and expiry date are not available at this time.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported products were collected in an expired set.The customer declined to provided further information.There was not a transfusion recipient or patient involved at the time, therefore no patient information is reasonably known at the time of the event.The collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
Investigation: a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.The customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported products were collected in an expired set.The customer declined to provided further information.There was not a transfusion recipient or patient involved at the time, therefore no patient information is reasonably known at the time of the event.The collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
Investigation: a disposable complaint history search could not be performed because the lot number was not provided by the customer during the complaint submission and the customer failed to provide the lot number.The customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.The customer history report indicates that within the last 90 days from the incident date, no further related issues have been reported for this customer.Root cause: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: the operator at the customer site failed to verify the expiry date of the disposable prior to use.A failure to verify expiration dates prior to releasing product from a blocked status within the terumo bct inventory system.
Event or Problem Description
The customer reported products were collected in an expired set.The customer declined to provided further information.There was not a transfusion recipient or patient involved at the time, therefore no patient information is reasonably known at the time of the event.The collection set is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Common Device Name: ACCESSORY PLATELET BAG, ISBT
• 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: 19547595
• Report Number: 1722028-2024-00247
• Device Sequence Number: 6711377
• Product Code: GKT
• UDI-Device Identifier: 05020583700307
• UDI-Public: 05020583700307
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BK190332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 70030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 08/16/2024; 09/06/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 08/26/2024; 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown