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

Model Number 10310

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem Hypervolemia (2664)

Event Date 06/22/2023

Event Type  malfunction  

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 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 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.

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 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.

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.

• Brand Name: SPECTRA OPTIA
• Type of Device: 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
• MDR Text Key: 319855774
• Report Number: 1722028-2023-00237
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183081
• 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
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/10/2024
• 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): Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 64 KG