MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS, PLT + AUTO PAS, PLS

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 03/26/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer provided two photographs of the reported incident.The photos confirmed the presence of fluid in the inlet coil tubing lines.Several small bubbles of air were verified in the ac line tubing, measuring approximately less than 1ml.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

The customer reported they noted air in the return line approximately 1/2 cm with small moveable bubble on either side of a large bubble.The donation was stopped before the air reached the donor (patient).Full patient id: (b)(6) due to eu personal data protection laws, the patient information is not available from the customer.Per the customer the patient outcome was listed as not applicable and it was confirmed no medical intervention was required.The customer is not able to return the set due to covid restrictions.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 they noted air in the return line approximately 1/2 cm with small moveable bubble on either side of a large bubble.The donation was stopped before the air reached the donor (patient).Full patient id: (b)(6) due to eu personal data protection laws, the patient information is not available from the customer.Per the customer the patient outcome was listed as not applicable and it was confirmed no medical intervention was required.The customer is not able to return the set due to covid restrictions.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 provided two photographs of the reported incident.The photos confirmed the presence of fluid in the inlet coil tubing lines.Several small bubbles of air were verified in the ac line tubing, measuring approximately less than 1ml.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.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 (rdf) was analyzed for this event.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 an ¿air detected at ac sensor¿ alert was presented.After the alert was cleared, the priming of the tubing kit with ac was successful, no alerts or alarms were generated.The operator has chosen to discontinue the procedure during the first draw cycle, during blood prime of the inlet line.As air was detected at the ac sensor during ac prime, unexpected air bubbles were present in the ac line.Although the air bubbles move towards the 1-to-2 manifold during blood prime, they will be pulled into the tubing kit by the inlet pump or the return pump temporary running in the reverse direction.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: * air being pulled into ac line via defective bacterial filter * the bacterial filter on the ac line was misassembled upside down allowing air to be pulled through the air vent * disposable manufacturing error resulting in excessive solvent used to bond the ac line to cassette causing a weakness in tubing material, which can lead to tears/breaks in tubing at the bond.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS, PLT + AUTO PAS, PLS
• 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: 14187737
• MDR Text Key: 298883272
• Report Number: 1722028-2022-00133
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2022

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 Catalogue Number: 82321
• Device Lot Number: 2112202130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 04/28/2022
• Supplement Dates FDA Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/31/2021
• 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: 46 YR
• Patient Sex: Male
• Patient Weight: 89 KG