MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLATELET PLASMA SET

Catalog Number 80337

Device Problems Use of Device Problem (1670); Defective Component (2292)

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

Event Date 05/31/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during disposable setup on a trima device, the alarm pressure test failure occurred.The customer noticed that the blood diversion clamp(yellow) was closed not the sample bag clamp(white) and then, the customer opened the yellow clamp and closed the white clamp.After that, something alarm occurred during collection.Patient information and outcome are unknown at this time.The collection 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

Investigation: the regional specialist confirmed with the sales representative that the issue was due to the operational error and was identified before the donor was connected.Terumo bct japan has confirmed the customer's statement and found the following: there was not anything wrong on the returned set.The white clamp and the blue clamp were closed and no leaks.The possible root cause was unknown.The customer supplied 3 photographs of the disposable kit.The photographs confirmed the presence of blood in the set, which indicated that the donor was connected.The clamps are present on the correct tubing lines and in the closed position.The sample bag appears mildly inflated with air.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.Corrective action: an internal capa has been initiated to evaluate air in the sample bag.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that during disposable setup on a trima device, the alarm pressure test failure occurred.The customer noticed that the blood diversion clamp(yellow) was closed not the sample bag clamp(white) and then, the customer opened the yellow clamp and closed the white clamp.After that, something alarm occurred during collection.Full donor id:(b)(6) per the customer the patient was reported as safe.The collection 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

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Correction: the regional specialist confirmed with sales that the customer was notified with regards to the cause of the incident for retraining purposes.Formal retraining was rejected by the customer since the notification was considered sufficient for future prevention.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during disposable setup on a trima device, the alarm pressure test failure occurred.The customer noticed that the blood diversion clamp(yellow) was closed not the sample bag clamp(white) and then, the customer opened the yellow clamp and closed the white clamp.After that, something alarm occurred during collection.Full donor id: (b)(6).Per the customer the patient was reported as safe.The collection 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 h.6 and h.10.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Correction: the regional specialist confirmed with sales that the customer was notified with regards to the cause of the incident for retraining purposes.Formal retraining was rejected by the customer since the notification was considered sufficient for future prevention.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be due to operator error because the sample bag clamp was not closed at the system prompt.

Event Description

The customer reported that during disposable setup on a trima device, the alarm pressure test failure occurred.The customer noticed that the blood diversion clamp(yellow) was closed not the sample bag clamp(white) and then, the customer opened the yellow clamp and closed the white clamp.After that, something alarm occurred during collection.Full donor id: (b)(6) per the customer the patient was reported as safe.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: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The customer returned the disposable kit to aid in the investigation.Tbct japan confirmed the presence of blood in the set, which indicated that the donor was connected.The clamps are present on the correct tubing lines and in the closed position.The sample bag appears mildly inflated with air.Correction: the regional specialist confirmed with sales that the customer was notified with regards to the cause of the incident for retraining purposes.Formal retraining was rejected by the customer since the notification was considered sufficient for future prevention.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be due to operator error because the sample bag clamp was not closed at the system prompt.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET 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 ; 3032314970
• MDR Report Key: 12093070
• MDR Text Key: 261915768
• Report Number: 1722028-2021-00225
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup,Followup
• Report Date: 10/04/2021

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: 01/01/2023
• Device Catalogue Number: 80337
• Device Lot Number: 2101044251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2021
• Initial Date FDA Received: 06/30/2021
• Supplement Dates Manufacturer Received: 07/19/2021; 07/26/2021; 09/30/2021; 11/09/2021
• Supplement Dates FDA Received: 07/23/2021; 08/17/2021; 10/04/2021; 11/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2021
• 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): Required Intervention; Other
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 82 KG