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

Model Number 82410

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Chest Pain (1776); Dyspnea (1816)

Event Date 09/05/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that during set up for a platelet/plasma donation, the operator received a 'pressure test error' alarm and continued the set up.At the start of the run, when the operator connected the needle to the donor, the operator opened the white clamp and the diversion bag clamp, but no blood was seen coming into the line.The operator then opened the blue clamp and suddenly heard the sound of air.Air entered the donor vein so the operator closed all clamps immediately.The donor then experienced chest pain and shortness of breath.The donor was sent to the icu.After 24 hours, the donor was no longer experiencing symptoms and was discharged home.Donor id is not available at this time.The set is not available for return for evaluation.

Manufacturer Narrative

This report is being filed to provide additional information in b.6, 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.The run data file (rdf) was analyzed for this event.Run data file analysis confirmed a ¿pressure test error¿ alert was generated three times during the tubing set test.Analysis showed that these alerts were generated because the access pressure sensor reading decreased more than expected after slight pump movement while the tubing set was positively pressurized.At the ¿pressure test error¿ alert screens, the operator was prompted to: ¿verify: - the clamps on the donor line and sample bag line are closed - no air is in the sample bag - the pump headers are loaded correctly - the cassette is loaded correctly - there are not obstructions behind the cassette or cassette tray - the ref selected matches tubing set loaded¿ based on the analysis of the run data file, it is suspected that these ¿pressure test failure¿ alerts were generated because the pinch clamp on the sample bag line was likely not properly occluding the line.If the clamp on the sample bag line is not properly occluding the line during the tubing set test, air can have a pathway to enter the sample bag.Investigation is in process.A follow up report will provided.

Event Description

The customer reported that during set up for a platelet/plasma donation, the operator received a 'pressure test error' alarm and continued the set up.At the start of the run, when the operator connected the needle to the donor, the operator opened the white clamp and the diversion bag clamp, but no blood was seen coming into the line.The operator then opened the blue clamp and suddenly heard the sound of air.Air entered the donor vein so the operator closed all clamps immediately.The donor then experienced chest pain and shortness of breath.The donor was sent to the icu.After 24 hours, the donor was no longer experiencing symptoms and was discharged home.Donor id is not available at this time.The set is not available for return for evaluation.

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 run data file (rdf) was analyzed for this event.Run data file analysis confirmed a ¿pressure test error¿ alert was generated three times during the tubing set test.Analysis showed that these alerts were generated because the access pressure sensor reading decreased more than expected after slight pump movement while the tubing set was positively pressurized.At the ¿pressure test error¿ alert screens, the operator was prompted to: ¿verify: the clamps on the donor line and sample bag line are closed - no air is in the sample bag; the pump headers are loaded correctly; the cassette is loaded correctly; there are not obstructions behind the cassette or cassette tray; the ref selected matches tubing set loaded¿ based on the analysis of the run data file, it is suspected that these ¿pressure test failure¿ alerts were generated because the pinch clamp on the sample bag line was likely not properly occluding the line.If the clamp on the sample bag line is not properly occluding the line during the tubing set test, air can have a pathway to enter the sample bag.The customer submitted ten photographs in lieu of the disposable set to aid investigation.Five of the pictures show the donor line, inlet line, sample bag and needle.These photos show some blood in the needle line and air in the inlet, ac and return lines.The sample bag does not appear to be inflated.The white pinch clamps on the needle line and the sample bag line are both open and flossed correctly on the tubing.The blue pinch clamp is noted to be flossed on the inlet line correctly and is closed.Two pictures show a close up of the white pinch clamps which appear to be flossed on the lines correctly and both are in the open position.There are no marks on the tubing to suggest the clamps had been closed.One picture shows a close up of the blue pinch clamp in the closed position and appears to be occluding the line adequately.The clamp is flossed on the tubing correctly also.Another picture shows the ac filter with no obvious defects or air inside the filter or in the filter inlet and outlet tubing.The last picture shows the cassette from the back and some prime fluid is noted in the cassette and tubing.Air is observed in the ac pump header tubing and in the recirc line to reservoir.No kinks or set defects are seen in the picture.Investigation is in process.A follow up report will provided.

Event Description

The customer reported that during set up for a platelet/plasma donation, the operator received a 'pressure test error' alarm and continued the set up.At the start of the run, when the operator connected the needle to the donor, the operator opened the white clamp and the diversion bag clamp, but no blood was seen coming into the line.The operator then opened the blue clamp and suddenly heard the sound of air.Air entered the donor vein so the operator closed all clamps immediately.The donor then experienced chest pain and shortness of breath.The donor was sent to the icu.After 24 hours, the donor was no longer experiencing symptoms and was discharged home.Donor id is not available at this time.The set is not available for return for evaluation.

Event Description

The customer reported that during set up for a platelet/plasma donation, the operator received a 'pressure test error' alarm and continued the set up.At the start of the run, when the operator connected the needle to the donor, the operator opened the white clamp and the diversion bag clamp, but no blood was seen coming into the line.The operator then opened the blue clamp and suddenly heard the sound of air.Air entered the donor vein so the operator closed all clamps immediately.The donor then experienced chest pain and shortness of breath.The donor was sent to the icu.After 24 hours, the donor was no longer experiencing symptoms and was discharged home.Donor id is not available at this time.The set is not available for return for evaluation.

Manufacturer Narrative

This report is being filed to provide additional information in 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.The run data file (rdf) was analyzed for this event.Run data file analysis confirmed a ¿pressure test error¿ alert was generated three times during the tubing set test.Analysis showed that these alerts were generated because the access pressure sensor reading decreased more than expected after slight pump movement while the tubing set was positively pressurized.At the ¿pressure test error¿ alert screens, the operator was prompted to: ¿verify: - the clamps on the donor line and sample bag line are closed - no air is in the sample bag - the pump headers are loaded correctly - the cassette is loaded correctly - there are not obstructions behind the cassette or cassette tray - the ref selected matches tubing set loaded¿ based on the analysis of the run data file, it is suspected that these ¿pressure test failure¿ alerts were generated because the pinch clamp on the sample bag line was likely not properly occluding the line.If the clamp on the sample bag line is not properly occluding the line during the tubing set test, air can have a pathway to enter the sample bag.The customer submitted ten photographs in lieu of the disposable set to aid investigation.Five of the pictures show the donor line, inlet line, sample bag and needle.These photos show some blood in the needle line and air in the inlet, ac and return lines.The sample bag does not appear to be inflated.The white pinch clamps on the needle line and the sample bag line are both open and flossed correctly on the tubing.The blue pinch clamp is noted to be flossed on the inlet line correctly and is closed.Two pictures show a close up of the white pinch clamps which appear to be flossed on the lines correctly and both are in the open position.There are no marks on the tubing to suggest the clamps had been closed.One picture shows a close up of the blue pinch clamp in the closed position and appears to be occluding the line adequately.The clamp is flossed on the tubing correctly also.Another picture shows the ac filter with no obvious defects or air inside the filter or in the filter inlet and outlet tubing.The last picture shows the cassette from the back and some prime fluid is noted in the cassette and tubing.Air is observed in the ac pump header tubing and in the recirc line to reservoir.No kinks or set defects are seen in the picture.The customer documented further details in the questionnaire.The customer did not provide an answer when asked if all luer connections tight.They confirmed there was no clotting in the channel or in the return reservoir.Medical intervention involved the patient being moved to the hospital icu and after 24 hours left the hospital without any symptoms.The name/title of who ordered this move was not provided by the customer.The blood diversion pouch was inflated with air, and pressure test error occurred 3 times.The operator just continued the procedure.The customer confirmed the patient was connected at the time, but not prematurely connected prior to ac prime.They also indicated that air was being drawn in through the ac line/filter.Investigation is in process.A follow up report will provided.

Event Description

The customer reported that during set up for a platelet/plasma donation, the operator received a 'pressure test error' alarm and continued the set up.At the start of the run, when the operator connected the needle to the donor, the operator opened the white clamp and the diversion bag clamp, but no blood was seen coming into the line.The operator then opened the blue clamp and suddenly heard the sound of air.Air entered the donor vein so the operator closed all clamps immediately.The donor then experienced chest pain and shortness of breath.The donor was sent to the icu.After 24 hours, the donor was no longer experiencing symptoms and was discharged home.Donor id is not available at this time.The set is not available for return for evaluation.

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.The run data file (rdf) was analyzed for this event.Run data file analysis confirmed a ¿¿¿pressure test error¿¿¿ alert was generated three times during the tubing set test.Analysis showed that these alerts were generated because the access pressure sensor reading decreased more than expected after slight pump movement while the tubing set was positively pressurized.At the ¿¿¿pressure test error¿¿¿ alert screens, the operator was prompted to: ¿¿¿verify: - the clamps on the donor line and sample bag line are closed - no air is in the sample bag - the pump headers are loaded correctly - the cassette is loaded correctly - there are not obstructions behind the cassette or cassette tray - the ref selected matches tubing set loaded¿¿¿ based on the analysis of the run data file, it is suspected that these ¿¿¿pressure test failure¿¿¿ alerts were generated because the pinch clamp on the sample bag line was likely not properly occluding the line.If the clamp on the sample bag line is not properly occluding the line during the tubing set test, air can have a pathway to enter the sample bag.The customer submitted ten photographs in lieu of the disposable set to aid investigation.Five of the pictures show the donor line, inlet line, sample bag and needle.These photos show some blood in the needle line and air in the inlet, ac and return lines.The sample bag does not appear to be inflated.The white pinch clamps on the needle line and the sample bag line are both open and flossed correctly on the tubing.The blue pinch clamp is noted to be flossed on the inlet line correctly and is closed.Two pictures show a close up of the white pinch clamps which appear to be flossed on the lines correctly and both are in the open position.There are no marks on the tubing to suggest the clamps had been closed.One picture shows a close up of the blue pinch clamp in the closed position and appears to be occluding the line adequately.The clamp is flossed on the tubing correctly also.Another picture shows the ac filter with no obvious defects or air inside the filter or in the filter inlet and outlet tubing.The last picture shows the cassette from the back and some prime fluid is noted in the cassette and tubing.Air is observed in the ac pump header tubing and in the recirc line to reservoir.No kinks or set defects are seen in the picture.The customer documented further details in the questionnaire.The customer did not provide an answer when asked if all luer connections tight.They confirmed there was no clotting in the channel or in the return reservoir.Medical intervention involved the patient being moved to the hospital icu and after 24 hours left the hospital without any symptoms.The name/title of who ordered this move was not provided by the customer.The blood diversion pouch was inflated with air, and pressure test error occurred 3 times.The operator just continued the procedure.The customer confirmed the patient was connected at the time, but not prematurely connected prior to ac prime.They also indicated that air was being drawn in through the ac line/filter.Root cause: a root cause assessment was performed for this complaint.Based on the available information, 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: * a clamp malfunction where the clamp skews to the side as it is closed.* the clamp does not fully occlude the tubing when closed due to interference between the clamp and the tube.Additional contributing factors could be related to user interface, where either the sample bag clamp was not closed at the system prompt, or the clamp was closed but it was skewed on the tubing enabling a portion of the tubing to allow air to pass.Based on the available information, a definitive root cause of the cracked cassette could not be determined, but it is likely due to one or a combination of the possible causes listed below: * mishandling at manufacturing or customer site * defective cassette from supplier.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMALRS PLATELET PLASMA RBC AUTOPAS 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: 15598388
• MDR Text Key: 301677349
• Report Number: 1722028-2022-00334
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824102
• UDI-Public: 05020583824102
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: BK190332
• 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: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2023
• Device Model Number: 82410
• Device Catalogue Number: 82410
• Device Lot Number: 2111184151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Required Intervention; Other
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 81 KG