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

Model Number 82446

Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 04/26/2022

Event Type  malfunction  

Event Description

The customer reported that they observed "two inches of air present in the return line from the set.The donation was stopped before air could enter donor." the customer declined to provide patient (donor) information.Donor unit id: (b)(4).

Manufacturer Narrative

Investigation: a used trima set containing blood was returned for investigation.It was noted that blood had circulated throughout the set.The disposable set was visually evaluated for any mis-assembly, leak location, or defect that could have contributed to the reported incident.Additionally, air bubbles were noted in the inlet and return lines.Furthermore, the return reservoir was full of blood.The device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that they observed "two inches of air present in the return line from the set.The donation was stopped before air could enter donor." donor unit id: (b)(6) the donor was reported as stable and healthy.

Manufacturer Narrative

Investigation: a used trima set containing blood was returned for investigation.It was noted that blood had circulated throughout the set.The disposable set was visually evaluated for any mis-assembly, leak location, or defect that could have contributed to the reported incident.Additionally, air bubbles were noted in the inlet and return lines.Furthermore, the return reservoir was full of blood.The device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that they observed "two inches of air present in the return line from the set.The donation was stopped before air could enter donor." donor unit id: (b)(6) the donor was reported as stable and healthy.

Manufacturer Narrative

Investigation: a used trima set containing blood was returned for investigation.It was noted that blood had circulated throughout the set.The disposable set was visually evaluated for any mis-assembly, leak location, or defect that could have contributed to the reported incident.Additionally, air bubbles were noted in the inlet and return lines.Furthermore, the return reservoir was full of blood.The device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.The run data file was analyzed for this event.The signals in the run data file did not reveal a conclusive cause for the air within the disposable set.There were no alerts and no unusual process variables identified.Root cause: 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: * foam from plasma drain is perceived as fluid by low level sensor resulting in microbubbles in return reservoir returned to donor during plasma flush causing air embolism to donor.* a defective lower level sensor.* obstructed low level sensor due to blood clots resulting in false detection of fluid rather than air leading to air to donor.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA PLATELET+SAMPLER, PLASMA, RBC
• 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: 14454415
• MDR Text Key: 300345557
• Report Number: 1722028-2022-00159
• 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,Followup
• Report Date: 05/19/2022

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 Expiration Date: 12/01/2023
• Device Model Number: 82446
• Device Catalogue Number: 5824462
• Device Lot Number: 2112204151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 11/28/2022; 01/27/2023
• Supplement Dates FDA Received: 12/02/2022; 02/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2021
• 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: 60 YR
• Patient Sex: Female