MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET

Catalog Number 4122201

Device Problems Fluid/Blood Leak (1250); Use of Device Problem (1670)

Patient Problem Hypovolemia (2243)

Event Date 07/26/2022

Event Type  Injury  

Manufacturer Narrative

Investigation: the product had been discarded and therefore an evaluation could not be conducted.The customer provided an image of the centrifuge basin with an unused set loaded into the filler.The customer had circled the upper bearing where it meets the braid indicating where the tubing was broken, and the dotted line indicating approximately where the blood splatter occurred.Terumo bct business manager spoke to the operator, and she thought it was likely a misload given the appearance when she opened the centrifuge.The run data file was analyzed for this event.Review of the dlog for this procedure confirmed the occurrence of the ¿leak was detected in centrifuge¿ alarm at 50 minutes into the run.The operator did not attempt to continue after the alarm, so no blood was returned to the patient.Rinseback was not performed.The most common causes of leaks in the centrifuge include not locking the lower loop collar in the filler latch, the channel not being flush with the top of the channel groove, and improper loading of the upper and lower bearings in the bearing holders.The customer reported the point of failure on the disposable was in the braided plastic near the top bearing holder.When disposable components in the centrifuge are misloaded, tubing can twist and cause leaks in the tubing lines.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.The device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the leakcount experienced by the customer.Correction: terumo bct strategic business manager emailed the customer the channel loading guidelines for review, and offered virtual training on the loading of the centrifuge.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported a leak occurred because of a tear in the braided plastic close to the upper bearing 50 minutes into a therapeutic plasma exchange (tpe) procedure.They were unable to perform rinseback and they did not perform custom prime.The patient's post hemoglobin dropped to 6.9 g/dl (20.7% hematocrit) from 23.4 % hematocrit.The patient required an unplanned unit of rbc transfusion.The patient was in stable condition following the procedure.The customer declined to provide patient identifier.The tpe set is not available for return because it was discarded by the customer.

Event Description

The customer reported a leak occurred because of a tear in the braided plastic close to the upper bearing 50 minutes into a therapeutic plasma exchange (tpe) procedure.They were unable to perform rinseback and they did not perform custom prime.The patient's post hemoglobin dropped to 6.9 g/dl (20.7% hematocrit) from 23.4 % hematocrit.The patient required an unplanned unit of rbc transfusion.The patient was in stable condition following the procedure.The customer declined to provide patient identifier.The tpe set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the product had been discarded and therefore an evaluation could not be conducted.The customer provided an image of the centrifuge basin with an unused set loaded into the filler.The customer had circled the upper bearing where it meets the braid indicating where the tubing was broken, and the dotted line indicating approximately where the blood splatter occurred.Terumo bct business manager spoke to the operator, and she thought it was likely a misload given the appearance when she opened the centrifuge.The run data file was analyzed for this event.Review of the dlog for this procedure confirmed the occurrence of the ¿leak was detected in centrifuge¿ alarm at 50 minutes into the run.The operator did not attempt to continue after the alarm, so no blood was returned to the patient.Rinseback was not performed.The most common causes of leaks in the centrifuge include not locking the lower loop collar in the filler latch, the channel not being flush with the top of the channel groove, and improper loading of the upper and lower bearings in the bearing holders.The customer reported the point of failure on the disposable was in the braided plastic near the top bearing holder.When disposable components in the centrifuge are misloaded, tubing can twist and cause leaks in the tubing lines.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.The device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the leakcount experienced by the customer.Correction: terumo bct strategic business manager emailed the customer the channel loading guidelines for review, and offered virtual training on the loading of the centrifuge.Root cause: a root cause assessment was performed for the leak.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: * incomplete seating of the centrifuge collar (hex) in the holder such as the latch pin not engaging * incomplete seating of the loop bearing into the upper bearing holder.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE 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: 15259083
• MDR Text Key: 298241297
• Report Number: 1722028-2022-00282
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: BK150251
• 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: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2024
• Device Catalogue Number: 4122201
• Device Lot Number: 2204216141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2022
• Initial Date FDA Received: 08/19/2022
• Supplement Dates Manufacturer Received: 09/07/2022
• Supplement Dates FDA Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/21/2022
• 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; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 74 KG