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

Model Number 82446

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Air/Gas in Device (4062)

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

Event Date 10/27/2021

Event Type  malfunction  

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 with no anomalies observed.Air bubbles were found in the blood in the return pump header and return line.All pressure sensors were inspected and determined to be functioning properly.Hemostats and gravity were used to manipulate fluid throughout the set and no fluid flow or line obstruction issues were noted.All witness and wear marks indicate individual loop and channel components were properly loaded.Investigation is in process.A follow-up report will be provided.

Event Description

Per the customer, the trima donation was through the first cycle the operator watched the return and noticed air going back to the donor.The procedure was stopped prior to any air returning to the donor.Per the customer no rinse back was completed.Full patient id: (b)(6) patient age is unknown at this time.Per the customer no air was returned to the patient (donor) and the procedure was stopped.

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 with no anomalies observed.Air bubbles were found in the blood in the return pump header and return line.All pressure sensors were inspected and determined to be functioning properly.Hemostats and gravity were used to manipulate fluid throughout the set and no fluid flow or line obstruction issues were noted.All witness and wear marks indicate individual loop and channel components were properly loaded.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.Investigation is in process.A follow-up report will be provided.

Event Description

Per the customer, the trima donation was through the first cycle the operator watched the return and noticed air going back to the donor.The procedure was stopped prior to any air returning to the donor.Per the customer no rinseback was completed.Full patient id: (b)(6) patient age is unknown at this time.Per the customer no air was returned to the patient (donor) and the procedure was stopped.

Manufacturer Narrative

This report is being filed to provide additional information in a.2, h.6 and h.10.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 with no anomalies observed.Air bubbles were found in the blood in the return pump header and return line.All pressure sensors were inspected and determined to be functioning properly.Hemostats and gravity were used to manipulate fluid throughout the set and no fluid flow or line obstruction issues were noted.All witness and wear marks indicate individual loop and channel components were properly loaded.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.The customer was performing a platelet collection.The procedure was stopped no rinseback given, nothing returned to the donor.The air was identified in the return line past the reservoir.All luer connections were tight and there was no clotting in the channel or in the return reservoir.The blood diversion pouch wasn't inflated with air.The patient was connected, but not prematurely connected prior to ac prime.Air was not being drawn in through the ac line/filter.All luer connections were tight.Investigation of the rdf showed that after the first draw cycle was completed 4.5 minutes into the procedure.6 seconds into the first return cycle the operator paused the procedure.4.7 minutes into the procedure the operator ended the collection.The signals in the run data file indicate that the device operated as intended and no unusual process variable was identified.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: * 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.

Event Description

Per the customer, the trima donation was through the first cycle the operator watched the return and noticed air going back to the donor.The procedure was stopped prior to any air returning to the donor.Per the customer no rinseback was completed.Full patient id: (b)(6) per the customer no air was returned to the patient (donor) and the procedure was stopped.

• 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: 12855858
• MDR Text Key: 282270526
• Report Number: 1722028-2021-00359
• 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: 11/19/2021

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: 05/01/2023
• Device Model Number: 82446
• Device Catalogue Number: 5824462
• Device Lot Number: 2105114251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2021
• Initial Date FDA Received: 11/22/2021
• Supplement Dates Manufacturer Received: 11/22/2022; 01/06/2023
• Supplement Dates FDA Received: 12/13/2022; 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2021
• 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: Male