MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA LRS PLT W/FILTER+SAMPLER+AUTOPAS

Catalog Number 82383

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 09/23/2021

Event Type  malfunction  

Event Description

The customer would like the run data file investigated to determine a possible cause for the overflow into the platelet concentrate when the additive solution was added.There was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.Donor unit #: (b)(6).Wbc count is not available at this time.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

Investigation: the customer returned a used trima disposable set, containing blood for investigation.The product bags were rf sealed and removed by the customer prior to return.The acda bag and competitor additive solution bags were returned connected to their respective lines.Blood was present throughout the inlet coil, inlet trap, centrifuge loop and return reservoir, which was noted to be approximately 100% full.Blood had travelled up the vent bag inlet tubing and the vent bag appeared to be approximately 20% full.Clumping as noted in the inlet trap.There was no evidence of a spillover.The centrifuge loop was visually inspected and no misassemblies or kinks were observed.There was no evidence of a misload, and the ears were snapped in place and secured to the upper and lower bearing.The lower hex was visually inspected, and the locking pin witness mark was evident, confirming that the lower hex had been secured in the optimal position.The tubing set was flow tested and no occlusions were identified.The run data file (rdf) was analyzed for this event.The generation of the ¿platelet additive solution prime error¿ was due to fluid seen at the lower level sensor soon than expected during the additive solution priming sequence.Possible causes for this alert are, but are not limited to: - channel clamps not closed - additive solution connected too soon - return pump occlusion error further analysis of the run data file did not show any abnormality during pas addition, the pas graph looked completely normal, with no indication of rbcs passing the rbc detector.Investigation is in process.A follow-up report will be provided.

Event Description

The customer would like the run data file investigated to determine a possible cause for the overflow into the platelet concentrate when the additive solution was added during a combined apheresis procedure.The product was transfused to a patient in oncology.Per the customer, no adverse events were reported in the recipient.Recipient id is not available at this time.Donor unit #: (b)(6) wbc count is not available at this time.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

Investigation: the customer returned a used trima disposable set, containing blood for investigation.The product bags were rf sealed and removed by the customer prior to return.The acda bag and competitor additive solution bags were returned connected to their respective lines.Blood was present throughout the inlet coil, inlet trap, centrifuge loop and return reservoir, which was noted to be approximately 100% full.Blood had travelled up the vent bag inlet tubing and the vent bag appeared to be approximately 20% full.Clumping as noted in the inlet trap.There was no evidence of a spillover.The centrifuge loop was visually inspected and no misassemblies or kinks were observed.There was no evidence of a misload, and the ears were snapped in place and secured to the upper and lower bearing.The lower hex was visually inspected, and the locking pin witness mark was evident, confirming that the lower hex had been secured in the optimal position.The tubing set was flow tested and no occlusions were identified.The run data file (rdf) was analyzed for this event.The generation of the ¿platelet additive solution prime error¿ was due to fluid seen at the lower level sensor soon than expected during the additive solution priming sequence.Possible causes for this alert are, but are not limited to: - channel clamps not closed - additive solution connected too soon - return pump occlusion error further analysis of the run data file did not show any abnormality during pas addition, the pas graph looked completely normal, with no indication of rbcs passing the rbc detector.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.

Manufacturer Narrative

Investigation: the customer returned a used trima disposable set, containing blood for investigation.The product bags were rf sealed and removed by the customer prior to return.The acda bag and competitor additive solution bags were returned connected to their respective lines.Blood was present throughout the inlet coil, inlet trap, centrifuge loop and return reservoir, which was noted to be approximately 100% full.Blood had travelled up the vent bag inlet tubing and the vent bag appeared to be approximately 20% full.Clumping as noted in the inlet trap.There was no evidence of a spillover.The centrifuge loop was visually inspected and no misassemblies or kinks were observed.There was no evidence of a misload, and the ears were snapped in place and secured to the upper and lower bearing.The lower hex was visually inspected, and the locking pin witness mark was evident, confirming that the lower hex had been secured in the optimal position.The tubing set was flow tested and no occlusions were identified.The run data file (rdf) was analyzed for this event.The generation of the ¿platelet additive solution prime error¿ was due to fluid seen at the lower level sensor soon than expected during the additive solution priming sequence.Possible causes for this alert are, but are not limited to: - channel clamps not closed - additive solution connected too soon - return pump occlusion error further analysis of the run data file did not show any abnormality during pas addition, the pas graph looked completely normal, with no indication of rbcs passing the rbc detector.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: the generation of the ¿platelet additive solution prime error¿ was due to fluid seen at the lower level sensor soon than expected during the additive solution priming sequence.Possible causes for this alert are, but are not limited to: - channel clamps not closed - additive solution connected too soon - return pump occlusion error further analysis of the run data file did not show any abnormality during pas addition, the pas graph looked completely normal, with no indication of rbcs passing the rbc detector.

Event Description

The customer would like the run data file investigated to determine a possible cause for the overflow into the platelet concentrate when the additive solution was added during a combined apheresis procedure.The product was transfused to a patient in oncology.Per the customer, no adverse events were reported in the recipient.The patient id was unavailable per region regulatory restrictions.Donor unit #: (b)(6) the residual leukocyte concentration was not tested ¿ only the platelet count was tested and reported as 1444 x10^9/l.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA LRS PLT W/FILTER+SAMPLER+AUTOPAS
• 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: 12682376
• MDR Text Key: 284641009
• Report Number: 1722028-2021-00336
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2021

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: 02/01/2023
• Device Catalogue Number: 82383
• Device Lot Number: 2102102230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 03/28/2022; 05/20/2022
• Supplement Dates FDA Received: 04/12/2022; 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 100 KG