MAUDE Adverse Event Report: TERUMO BCT TRIAM ACCEL; TRIMA PLT + SAMPLER, PLASMA, AUTOR

Model Number 82616

Device Problems Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993); Air/Gas in Device (4062)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the operator checked on donor during first return cycle and found a leak where the manifold attaches to the draw/ return line.Air was present in tubing, per the customer.Patient outcome and patient information are not available at this time.Terumo bct is awaiting the return of the disposable set.

Manufacturer Narrative

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

Event Description

The customer reported that the operator checked on donor during first return cycle and found a leak where the manifold attaches to the draw/ return line.Air was present in tubing, per the customer.Patient identifier and age are not available at this time.Per the customer the patient was reported as stable and healthy.Terumo bct is awaiting the return of the disposable set.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Two photographs were submitted by the customer.Both photos show the inlet manifold, the blue pinch clamp, which is open, and the white pinch clamp which appears to be closed.The lines all contain blood and air bubbles are observed in the ac, draw and return lines.A leak is also confirmed at the entry of the ac tubing in the port of the manifold.The run data file (rdf) was analyzed for this event.The rdf analysis showed that there were two 'draw pressure too low' alerts in the first minute of the procedure and one 'centrifuge pressure high' alert in the fourth minute.At the time of the high pressure alarm, the operator stopped the procedure.This all occurred before the first cycle was complete.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that the operator checked on donor during first return cycle and found a leak where the manifold attaches to the draw/ return line.Air was present in tubing, per the customer.Patient identifier and age are not available.Per the customer the patient was reported as stable and healthy.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in d.5, d.9, h.6 and h.10.Investigation: a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.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 that the operator checked on donor during first return cycle and found a leak where the manifold attaches to the draw/ return line.Air was present in tubing, per the customer.Patient identifier and age are not available.Per the customer the patient was reported as stable and healthy.The collection set is not available for return because it was discarded by the customer.

Event Description

The customer reported that the operator checked on donor during first return cycle and found a leak where the manifold attaches to the draw/ return line.Air was present in tubing, per the customer.The customer declined to provide patient identifier.Per the customer the patient was reported as stable and healthy.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide investigation: a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Two photographs were submitted by the customer.Both photos show the inlet manifold, the blue pinch clamp, which is open, and the white pinch clamp which appears to be closed.The lines all contain blood and air bubbles are observed in the ac, draw and return lines.A leak is also confirmed at the entry of the ac tubing in the port of the manifold.The run data file (rdf) was analyzed for this event.The rdf analysis showed that there were two 'draw pressure too low' alerts in the first minute of the procedure and one 'centrifuge pressure high' alert in the fourth minute.At the time of the high pressure alarm, the operator stopped the procedure.This all occurred before the first cycle was complete.Root cause: the root cause of the air to donor potential was determined to be due to a leak in the manifold of the inlet coil.A definitive root cause of the leak could not be determined but it is likely due to one or a combination of the possible causes listed below: - inadequate contact of the tubing with the bond socket after solvent application - insufficient application of solvent to the tubing - inadequate insertion of the tube into/over the bond socket.

• Brand Name: TRIAM ACCEL
• Type of Device: TRIMA PLT + SAMPLER, PLASMA, AUTOR
• 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: 14187540
• MDR Text Key: 298883216
• Report Number: 1722028-2022-00132
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583826168
• UDI-Public: 05020583826168
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,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: 01/01/2024
• Device Model Number: 82616
• Device Catalogue Number: 3826162
• Device Lot Number: 2201142232
• 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: 01/27/2023; 01/27/2023; 01/27/2023; 01/27/2023
• Supplement Dates FDA Received: 05/19/2022; 11/29/2022; 12/20/2022; 02/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/21/2022
• 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: 28 YR
• Patient Sex: Female