MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLT SAMPLER, AUTO PAS, MLTPLS S

Catalog Number 82310

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 03/22/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer returned a used trima set for investigation.Upon receipt of the set, it was noted that the customer had rf sealed the donor line and removed/rf sealed the sample bag/tubing.Visual inspection confirmed the presence of blood throughout the set in the inlet coil, cassette, channel, return reservoir and vent bag.The vent bag was also partially inflated (approx.50%) with air.No leaks, kinks/occlusions, misassemblies, missing or defective parts were identified.The presence of air was noted in the access line, inlet line, draw/return pressure diaphragm, inlet trap and reservoir.No air was observed in the return line, return pump header tubing or ac line.Air bubbles were also noted in the plasma and platelet pump header tubing.No evidence of clotting was observed in the cassette, tubing, channel or connector.In summary, no disposable defects were identified.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that in the first return cycle, the operator noticed a lot of air bubbles in the return line.Per the customer, the current patient condition is "safe and sound".No medical intervention was necessary for this event.Patient id, age, and weight are 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.

Event Description

The customer reported that in the first return cycle, the operator noticed a lot of air bubbles in the return line.Per the customer, the current patient condition is "safe and sound".No medical intervention was necessary for this event.Due to eu personal data protection laws, further patient information is not available from the customer.Donor gender and weight were obtained from the run data file (rdf).A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.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 a.4, b.5, b.6, h.6 and h.10.Investigation: the customer returned a used trima set for investigation.Upon receipt of the set, it was noted that the customer had rf sealed the donor line and removed/rf sealed the sample bag/tubing.Visual inspection confirmed the presence of blood throughout the set in the inlet coil, cassette, channel, return reservoir and vent bag.The vent bag was also partially inflated (approx.50%) with air.No leaks, kinks/occlusions, misassemblies, missing or defective parts were identified.The presence of air was noted in the access line, inlet line, draw/return pressure diaphragm, inlet trap and reservoir.No air was observed in the return line, return pump header tubing or ac line.Air bubbles were also noted in the plasma and platelet pump header tubing.No evidence of clotting was observed in the cassette, tubing, channel or connector.In summary, no disposable defects were identified.The run data file (rdf) was analyzed for this event.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.Priming of the tubing kit and the first full draw cycle was successful, no alerts or alarms were generated.The low and high level sensors display an expected pattern during blood prime, first draw cycle.The operator chose to end the procedure 4 seconds into the first return cycle.The analysis of the run data file did not conclusively identify the cause of the air in the return line reported by the customer.Potential causes of air being present in the tubing set include, but 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 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.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: the customer returned a used trima set for investigation.Upon receipt of the set, it was noted that the customer had rf sealed the donor line and removed/rf sealed the sample bag/tubing.Visual inspection confirmed the presence of blood throughout the set in the inlet coil, cassette, channel, return reservoir and vent bag.The vent bag was also partially inflated (approx.50%) with air.No leaks, kinks/occlusions, misassemblies, missing or defective parts were identified.The presence of air was noted in the access line, inlet line, draw/return pressure diaphragm, inlet trap and reservoir.No air was observed in the return line, return pump header tubing or ac line.Air bubbles were also noted in the plasma and platelet pump header tubing.No evidence of clotting was observed in the cassette, tubing, channel or connector.In summary, no disposable defects were identified.The run data file (rdf) was analyzed for this event.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.Priming of the tubing kit and the first full draw cycle was successful, no alerts or alarms were generated.The low and high level sensors display an expected pattern during blood prime, first draw cycle.The operator chose to end the procedure 4 seconds into the first return cycle.The analysis of the run data file did not conclusively identify the cause of the air in the return line reported by the customer.Potential causes of air being present in the tubing set include, but 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 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.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: tubing length changes, algorithm error, full occlusion of the line due to kink or other blockages.Line of the sample pouch on the donor line not fully closed prior pressing start button.

Event Description

The customer reported that in the first return cycle, the operator noticed a lot of air bubbles in the return line.Per the customer, the current patient condition is "safe and sound".No medical intervention was necessary for this event.Due to eu personal data protection laws, further patient information is not available from the customer.Donor gender and weight were obtained from the run data file (rdf).A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.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 PLT SAMPLER, AUTO PAS, MLTPLS S
• 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: 14119000
• MDR Text Key: 294641906
• Report Number: 1722028-2022-00125
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: BU
• 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: 04/15/2022

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: 06/01/2023
• Device Catalogue Number: 82310
• Device Lot Number: 2106171230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/15/2022
• Supplement Dates Manufacturer Received: 06/07/2022; 06/07/2022
• Supplement Dates FDA Received: 06/03/2022; 06/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2021
• 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: 89 KG