MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET + AUTO PAS, PLASMA SET

Catalog Number 82321

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 12/27/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer reported that they ran a fluid run since and does not see any issue.The run data file (rdf) was analyzed for this event.Review of the run data file confirms that the tubing set was loaded successfully and passed the tubing set test.The aps graph during the tubing set test looked completely normal.At the beginning of ac prime a ¿air detected at ac sensor¿ was generated.After the alert was cleared, the priming of the tubing kit was successful, no alerts or alarms were generated.The operator has chosen to discontinue the procedure during the first draw cycle.The run data file analysis did not conclusively identify the cause of air being in the return line reported by the customer.Potential causes for air being present in the tubing set include, but a are not limited to: - line of the sample pouch on the donor line not fully closed prior pressing start button - residual air being pulled from the 3-1 manifold - air being pulled through ac line - a manufacturing defect may have been present on the tubing kit investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that just before the first return on a procedure they observed air in the return lines.The machine had alerted to no anticoagulant (ac) but when checked it was working as normal.The donation was stopped before the air was returned.Per the customer no medical intervention was required for this event.Per the customer, all luers were tight, the sample bag was not inflated and there was no clotting in the channel or reserve reservoir.Patient id and age are not available at this time.The disposables set is not available for return because it was discarded by the customer.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.

Event Description

The customer reported that just before the first return on a procedure they observed air in the return lines.The machine had alerted to no anticoagulant (ac) but when checked it was working as normal.The donation was stopped before the air was returned.Per the customer no medical intervention was required for this event.Per the customer, all luers were tight, the sample bag was not inflated and there was no clotting in the channel or reserve reservoir.Due to eu personal data protection laws, the patient information is not available from the customer.Donor gender and weight were obtained from the run data file (rdf).The disposables set is not available for return because it was discarded by the customer.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

This report is being filed to provide additional information in b.5, h.6 and h.10.Investigation: the customer reported that they ran a fluid run since and does not see any issue.The run data file (rdf) was analyzed for this event.Review of the run data file confirms that the tubing set was loaded successfully and passed the tubing set test.The aps graph during the tubing set test looked completely normal.At the beginning of ac prime a ¿air detected at ac sensor¿ was generated.After the alert was cleared, the priming of the tubing kit was successful, no alerts or alarms were generated.The operator has chosen to discontinue the procedure during the first draw cycle.The run data file analysis did not conclusively identify the cause of air being in the return line reported by the customer.Potential causes for air being present in the tubing set include, but a are not limited to: - line of the sample pouch on the donor line not fully closed prior pressing start button - residual air being pulled from the 3-1 manifold - air being pulled through ac line - a manufacturing defect may have been present on the tubing kit a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.Photographs were submitted in lieu of the disposable set to aid in the investigation.The photos confirmed the presence of small amounts of air in both the inlet and return lines.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: review of the run data file confirms that the tubing kit was loaded successfully and passed the tubing set test.The aps graph during the tubing set test looked completely normal.At the beginning of ac prime a ¿air detected at ac sensor¿ was generated.After the alert was cleared, the priming of the tubing kit was successful, no alerts or alarms were generated.The operator has chosen to discontinue the procedure during the first draw cycle.The run data file analysis did not conclusively identify the cause of air being in the return line reported by the customer.Potential causes for air being present in the tubing set include, but a are not limited to: - line of the sample pouch on the donor line not fully closed prior pressing start button - residual air being pulled from the 3-1 manifold - air being pulled through ac line - a manufacturing defect may have been present on the tubing kit.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET + AUTO PAS, PLASMA 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: 13334268
• MDR Text Key: 286597093
• Report Number: 1722028-2022-00027
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

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: 08/01/2023
• Device Catalogue Number: 82321
• Device Lot Number: 2108102130
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/30/2021
• Initial Date FDA Received: 01/24/2022
• Supplement Dates Manufacturer Received: 01/26/2022
• Supplement Dates FDA Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/17/2021
• 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 Sex: Male
• Patient Weight: 83 KG