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

Model Number 82300

Device Problems Leak/Splash (1354); Use of Device Problem (1670); No Apparent Adverse Event (3189); Device Handling Problem (3265)

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

Event Date 08/07/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation: one used trima set containing blood was received by terumo bct for investigation.Initial inspection noted the ac bag, product bags and inlet coil were rf sealed and removed prior to return.A leak was confirmed by the presence of blood on the exterior of the set and in the bag the set was returned in.The braid was fully saturated with blood.Visual inspection noted a witness mark on the low hex that confirms it was not loaded optimally and witness marks on the lower and upper bearing were unable to be identified.The ears on both bearings were intact and fully attached.The braid was detached by the investigator to examine the 4-lumen underneath and no holes or leaks were identified.The leak could not be identified on the set.The set was further inspected for any kinks, missing parts or misassembles and none were noted.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported a leakage on the tubing under the network.Upon review, it was found that an expired set was used on a healthy donor.The procedure was performed on (b)(6) 2021 and the set expired on (b)(6) 2020.Patient outcome is reported as "good" and no serious injury or medical intervention occurred.Patient id is not available at this time.

Event Description

The customer reported a leakage on the tubing under the network.Upon review, it was found that an expired set was used on a healthy donor.The procedure was performed on (b)(6) 2021 and the set expired on (b)(6) 2020.Patient outcome is reported as "good" and no serious injury or medical intervention occurred.Due to eu personal data protection laws, the patient identifier is not available from the customer.

Manufacturer Narrative

Investigation: one used trima set containing blood was received by terumo bct for investigation.Initial inspection noted the ac bag, product bags and inlet coil were rf sealed and removed prior to return.A leak was confirmed by the presence of blood on the exterior of the set and in the bag the set was returned in.The braid was fully saturated with blood.Visual inspection noted a witness mark on the low hex that confirms it was not loaded optimally and witness marks on the lower and upper bearing were unable to be identified.The ears on both bearings were intact and fully attached.The braid was detached by the investigator to examine the 4-lumen underneath and no holes or leaks were identified.The leak could not be identified on the set.The set was further inspected for any kinks, missing parts or misassembles and none were noted.A disposable complaint history search was performed for this lot and found no reports for similar issues either the leak or the use of an expired set.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: based on the available information the root cause was determined to be operator error due to the customer's unintentional use of an expired set.

Manufacturer Narrative

This report is being filed to provide additional information in h.10.Investigation: one used trima set containing blood was received by terumo bct for investigation.Initial inspection noted the ac bag, product bags and inlet coil were rf sealed and removed prior to return.A leak was confirmed by the presence of blood on the exterior of the set and in the bag the set was returned in.The braid was fully saturated with blood.Visual inspection noted a witness mark on the low hex that confirms it was not loaded optimally and witness marks on the lower and upper bearing were unable to be identified.The ears on both bearings were intact and fully attached.The braid was detached by the investigator to examine the 4-lumen underneath and no holes or leaks were identified.The leak could not be identified on the set.The set was further inspected for any kinks, missing parts or misassembles and none were noted.A disposable complaint history search was performed for this lot and found no reports for similar issues either the leak or the use of an expired set.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported a leakage on the tubing under the network.Upon review, it was found that an expired set was used on a healthy donor.The procedure was performed on (b)(6) 2021 and the set expired on (b)(6) 2020.Patient outcome is reported as "good" and no serious injury or medical intervention occurred.Patient id is not available at this time.

Manufacturer Narrative

Investigation: one used trima set containing blood was received by terumo bct for investigation.Initial inspection noted the ac bag, product bags and inlet coil were rf sealed and removed prior to return.A leak was confirmed by the presence of blood on the exterior of the set and in the bag the set was returned in.The braid was fully saturated with blood.Visual inspection noted a witness mark on the low hex that confirms it was not loaded optimally and witness marks on the lower and upper bearing were unable to be identified.The ears on both bearings were intact and fully attached.The braid was detached by the investigator to examine the 4-lumen underneath and no holes or leaks were identified.The leak could not be identified on the set.The set was further inspected for any kinks, missing parts or misassembles and none were noted.A disposable complaint history search was performed for this lot and found no reports for similar issues either the leak or the use of an expired set.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 a leakage on the tubing under the network.Upon review, it was found that an expired set was used on a healthy donor.The procedure was performed on (b)(6) 2021 and the set expired on 11/01/2020.Patient outcome is reported as "good" and no serious injury or medical intervention occurred.Patient id is not available at this time.

Manufacturer Narrative

Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.Per follow up with the customer, the lot number was updated and there was no use of an expired set.One used trima set containing blood was received by terumo bct for investigation.Initial inspection noted the ac bag, product bags and inlet coil were rf sealed and removed prior to return.A leak was confirmed by the presence of blood on the exterior of the set and in the bag the set was returned in.The braid was fully saturated with blood.Visual inspection noted a witness mark on the low hex that confirms it was not loaded optimally and witness marks on the lower and upper bearing were unable to be identified.The ears on both bearings were intact and fully attached.The braid was detached by the investigator to examine the 4-lumen underneath and no holes or leaks were identified.The leak could not be identified on the set.The set was further inspected for any kinks, missing parts or misassembles and none were noted.A disposable complaint history search was performed for this lot and found no reports for similar issues either the leak or the use of an expired set.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Corrected root cause: a root cause assessment was performed for this complaint.Based on the available information, the root cause for the reported incident (the leak) was due a loading issue of the set at the customer site.Due to the nature of the design of the product, the method used to load the set is vital to ensure the system functions properly.No further reporting will be provided as this does not represent a reportable event.

Event Description

The customer reported a leakage on the tubing under the network.Upon review, it was thought that an expired set was used on a healthy donor.The procedure was performed on (b)(6) 2021 and the set expired on 01/01/2023.Therefore, no expired set use occurred.Patient outcome is reported as "good" and no serious injury or medical intervention occurred.Due to eu personal data protection laws, the patient identifier is not available from the customer.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS 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
• MDR Report Key: 12392757
• MDR Text Key: 270535394
• Report Number: 1722028-2021-00286
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583823006
• UDI-Public: 05020583823006
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: BK180231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/31/2021

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 Model Number: 82300
• Device Catalogue Number: 5823001
• Device Lot Number: 2101074151
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/06/2021
• Initial Date FDA Received: 08/31/2021
• Supplement Dates Manufacturer Received: 01/18/2023; 02/16/2023; 03/27/2023; 04/03/2023
• Supplement Dates FDA Received: 02/10/2023; 03/07/2023; 03/28/2023; 05/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2021
• 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: 24 YR
• Patient Sex: Male
• Patient Weight: 100 KG