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

Model Number	10310
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hypervolemia (2664)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number and expiry information are not available at this time.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer called terumo bct customer support because the natural saline (ns) continued to drip during a procedure.The operator was using a 1 liter bag of ns and the terumo bct customer support specialist asked if both ns roller clamps were closed.The operator discovered that the red roller clamp was not closed.The operator closed the saline roller clamp and the ns stopped dripping.The operator then had an interface taking too long to establish alarm.Terumo bct customer support told her to lower the hct.The initial hct entered was 38.The operator lowered it down to 35.Terumo bct customer support indicated that this action had diluted the hct in the channel.The operator informed that the interface was about half of the connector when terumo bct customer support had her lower the hct and they instructed that if she has the alarm again she may need to lower the hct again.Patient information and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.
Event or Problem Description
The customer called terumo bct customer support because the natural saline (ns) continued to drip during a continuous mononuclear cell (cmnc) collection.The operator was using a 1 liter bag of ns and the terumo bct customer support specialist asked if both ns roller clamps were closed.The operator discovered that the red roller clamp was not closed.The operator closed the saline roller clamp and the ns stopped dripping.The operator then had an interface taking too long to establish alarm.Terumo bct customer support told her to lower the hct.The initial hct entered was 38.The operator lowered it down to 35.Terumo bct customer support indicated that this action had diluted the hct in the channel.The operator informed that the interface was about half of the connector when terumo bct customer support had her lower the hct and they instructed that if she has the alarm again she may need to lower the hct again.The customer failed to respond to multiple attempts to obtain essential information such as patient information and outcome.The collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
Investigation: a disposable lot history could not be conducted since the customer failed to respond to multiple attempts to obtain the disposable lot number.The customer did not respond to multiple requests for lot number.Therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Root cause: a root cause assessment was performed for the unintended saline bolus to the patient.Based on the customer's statements, the operator failed to follow the screen prompts to fully close the inlet saline roller clamp at the end of saline prime divert.The saline entered the system and diluted the incoming patient¿s blood, causing the interface took too long to establish alarms.
Event or Problem Description
The customer called terumo bct customer support because the natural saline (ns) continued to drip during a continuous mononuclear cell (cmnc) collection.The operator was using a 1 liter bag of ns and the terumo bct customer support specialist asked if both ns roller clamps were closed.The operator discovered that the red roller clamp was not closed.The operator closed the saline roller clamp and the ns stopped dripping.The operator then had an interface taking too long to establish alarm.Terumo bct customer support told her to lower the hct.The initial hct entered was 38.The operator lowered it down to 35.Terumo bct customer support indicated that this action had diluted the hct in the channel.The operator informed that the interface was about half of the connector when terumo bct customer support had her lower the hct and they instructed that if she has the alarm again she may need to lower the hct again.The customer declined to provide the patient identifier.The collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
This report is being filed to provide additional information.Corrected information is provided in b.5 and h.11.Investigation: investigation is in process.A follow-up report will be provided.Root cause: a root cause assessment was performed for the unintended saline bolus to the patient.Based on the customer's statements, the operator failed to follow the screen prompts to fully close the inlet saline roller clamp at the end of saline prime divert.The saline entered the system and diluted the incoming patient¿s blood, causing the interface took too long to establish alarms.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: a root cause assessment was performed for the unintended saline bolus to the patient.Based on the customer's statements, the operator failed to follow the screen prompts to fully close the inlet saline roller clamp at the end of saline prime divert.The saline entered the system and diluted the incoming patient¿s blood, causing the interface took too long to establish alarms.
Event or Problem Description
The customer called terumo bct customer support because the natural saline (ns) continued to drip during a continuous mononuclear cell (cmnc) collection.The operator was using a 1 liter bag of ns and the terumo bct customer support specialist asked if both ns roller clamps were closed.The operator discovered that the red roller clamp was not closed.The operator closed the saline roller clamp and the ns stopped dripping.The operator then had an interface taking too long to establish alarm.Terumo bct customer support told her to lower the hct.The initial hct entered was 38.The operator lowered it down to 35.Terumo bct customer support indicated that this action had diluted the hct in the channel.The operator informed that the interface was about half of the connector when terumo bct customer support had her lower the hct and they instructed that if she has the alarm again she may need to lower the hct again.The customer declined to provide the patient identifier.The collection set is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Common Device Name: SPECTRA OPTIA IDL 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: 17319693
• Report Number: 1722028-2023-00237
• Device Sequence Number: 4057972
• Product Code: LKN
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K183081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/13/2023

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
• Operator of Device: Health Professional
• Device Model Number: 10310
• Device Catalogue Number: 10310
• Device Lot Number: 2303093141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 03/22/2024; 04/10/2024; 05/03/2024
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 03/29/2024; 04/23/2024; 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 64 KG