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

Model Number 12220

Device Problems Use of Device Problem (1670); Obstruction of Flow (2423)

Patient Problems Nausea (1970); Loss of consciousness (2418)

Event Date 01/27/2022

Event Type  Injury  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf does not show a conclusive root cause that indicates the cause of the return saline line being opened and the return line to the patient being closed.If the return saline clamp was opened and the inlet line was closed during the procedure the return fluid was being returned to the saline bag.This was described by the customer as the event that occurred.Per the customer, the hospital and department has done their own investigation and determined it was human error.The customer states they do not need any retraining.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a sickle cell patient had a code blue during a red blood cell exchange (rbcx) procedure.About 20 minutes into the depletion, the patient started to have complaints of n/v, lost consciousness, stopped breathing and had a weak pulse.The operator also noticed the return saline roller clamp was left open during the run.The normal saline (ns) bag on the prime line was full and appeared like it was about to burst.The replacement 500 ns bag appeared to be empty.The operator tried to bolus the patient by pushing the ns in the prime bag to the patient on the return line but it wouldn't go through to the patient.Per the customer it was assumed the line was clotted, and the operator switched out the ns bag and gave the patient 200 mls bolus through the access line with no issues.The patient also received 5% albumin-500 mls and 1 unit of prbc.The patient was then transported to the er.Patient identifier is unknown at this time.Per the customer the patient was reported as "stable".The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf does not show a conclusive root cause that indicates the cause of the return saline line being opened and the return line to the patient being closed.If the return saline clamp was opened and the inlet line was closed during the procedure the return fluid was being returned to the saline bag.This was described by the customer as the event that occurred.Per the customer, the hospital and department has done their own investigation and determined it was human error.The customer states they do not need any retraining.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a sickle cell patient had a code blue during a red blood cell exchange (rbcx) procedure.About 20 minutes into the depletion, the patient started to have complaints of n/v, lost consciousness, stopped breathing and had a weak pulse.The operator also noticed the return saline roller clamp was left open during the run.The normal saline (ns) bag on the prime line was full and appeared like it was about to burst.The replacement 500 ns bag appeared to be empty.The operator tried to bolus the patient by pushing the ns in the prime bag to the patient on the return line but it wouldn't go through to the patient.Per the customer it was assumed the line was clotted, and the operator switched out the ns bag and gave the patient 200 mls bolus through the access line with no issues.The patient also received 5% albumin-500 mls and 1 unit of prbc.The patient was then transported to the er.Patient identifier is unknown at this time.Per the customer the patient was reported as "stable".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 h.6 and h.10.Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf does not show a conclusive root cause that indicates the cause of the return saline line being opened and the return line to the patient being closed.If the return saline clamp was opened and the inlet line was closed during the procedure the return fluid was being returned to the saline bag.This was described by the customer as the event that occurred.Per the customer, the hospital and department has done their own investigation and determined it was human error.The customer states they do not need any retraining.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.Correction: terumo bct clinical support offered the customer retraining for the operator clamping error.The customer declined the retraining since they had already addressed the operator error internally.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a sickle cell patient had a code blue during a red blood cell exchange (rbcx) procedure.About 20 minutes into the depletion, the patient started to have complaints of n/v, lost consciousness, stopped breathing and had a weak pulse.The operator also noticed the return saline roller clamp was left open during the run.The normal saline (ns) bag on the prime line was full and appeared like it was about to burst.The replacement 500 ns bag appeared to be empty.The operator tried to bolus the patient by pushing the ns in the prime bag to the patient on the return line but it wouldn't go through to the patient.Per the customer it was assumed the line was clotted, and the operator switched out the ns bag and gave the patient 200 mls bolus through the access line with no issues.The patient also received 5% albumin-500 mls and 1 unit of prbc.The patient was then transported to the er.Patient identifier is unknown at this time.Per the customer the patient was reported as "stable".The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf does not show a conclusive root cause that indicates the cause of the return saline line being opened and the return line to the patient being closed.If the return saline clamp was opened and the inlet line was closed during the procedure the return fluid was being returned to the saline bag.This was described by the customer as the event that occurred.Per the customer, the hospital and department has done their own investigation and determined it was human error.The customer states they do not need any retraining.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.Terumo bct service technician checked out the machine at the customer site.The machine completed all functional testing without any alarms or failures occurring.Machine operations were verified.Correction: terumo bct clinical support offered the customer retraining for the operator clamping error.The customer declined the retraining since they had already addressed the operator error internally.Root cause: based on the customer's description and dlog analysis, the operator had inadvertently left the return saline roller clamp open and the return pinch clamp closed.All of the replacement fluids were diverted into the saline bag via the open return saline roller while the return clamp remained closed.Therefore, the root cause was determined to be operator error.

Event Description

The customer reported that a sickle cell patient had a code blue during a red blood cell exchange (rbcx) procedure.About 20 minutes into the depletion, the patient started to have complaints of n/v, lost consciousness, stopped breathing and had a weak pulse.The operator also noticed the return saline roller clamp was left open during the run.The normal saline (ns) bag on the prime line was full and appeared like it was about to burst.The replacement 500 ns bag appeared to be empty.The operator tried to bolus the patient by pushing the ns in the the prime bag to the patient on the return line but it wouldn't go through to the patient.Per the customer it was assumed the line was clotted, and the operator switched out the ns bag and gave the patient 200 mls bolus through the access line with no issues.The patient also received 5% albumin-500 mls and 1 unit of prbc.The patient was then transported to the er.The customer declined to provide the patient identifier.Per the customer the patient was reported as "stable".The collection set is not available for return because it was discarded by the customer.

Event Description

The customer reported that a sickle cell patient had a code blue during a red blood cell exchange (rbcx) procedure.About 20 minutes into the depletion, the patient started to have complaints of n/v, lost consciousness, stopped breathing and had a weak pulse.The operator also noticed the return saline roller clamp was left open during the run.The normal saline (ns) bag on the prime line was full and appeared like it was about to burst.The replacement 500 ns bag appeared to be empty.The operator tried to bolus the patient by pushing the ns in the prime bag to the patient on the return line but it wouldn't go through to the patient.Per the customer it was assumed the line was clotted, and the operator switched out the ns bag and gave the patient 200 mls bolus through the access line with no issues.The patient also received 5% albumin-500 mls and 1 unit of prbc.The patient was then transported to the er.The customer declined to provide the patient identifier.Per the customer the patient was reported as "stable".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 h.10.Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf does not show a conclusive root cause that indicates the cause of the return saline line being opened and the return line to the patient being closed.If the return saline clamp was opened and the inlet line was closed during the procedure the return fluid was being returned to the saline bag.This was described by the customer as the event that occurred.The procedure was initiated at 10:38 and at 10:57, 19 minutes into the procedure the system prompted the operator to change the replacement fluid to rbc for the exchange.The customer stated that the 500 ml replacement saline bag was empty but the dlog analysis confirmed that a total of 719 ml of replacement fluid was used, and only 397 ml saline was for the depletion phase.It was likely that the operator did not switch over to the rbc replacement fluid following the system prompt resulting in an additional 103 ml saline bag to be pushed into the saline bag via the open return saline roller clamp.At 11:06, 9 minutes after the system prompted to change out the replacement fluid, the system generated 'replacement fluid was not detected' alarm.The operator must have switched over to rbc replacement since an additional 322 ml replacement fluid was returned and went back up into the saline bag.Total remove volume = 871ml (39ml ac, 18ml saline, 814ml of blood at approximately 49% hct).Residual blood in the set with no rinseback = ~141 ml blood warmer tubing =50 ml total volume of whole blood processed = 1674 ml the patient had not received either the saline or the rbc during the depletion/exchange procedure.The patient's total blood loss is estimated as follows: patient's blood loss = 1674 ml / 5907 ml x 100) = 28.34 %.The operator tried to give a bolus to the patient by pushing the ns in the prime bag to the patient using the return line but the return had clotted since it had been idle for about 29 minutes.They switched out the ns bag and gave the patient 200 ml ns bolus through the access line with no issues.The patient also received 500 ml 5% albumin and 1 unit of prbc as part of the medical intervention as well as the use of a non-rebreather mask for the respiratory code.The patient was then transported to the er.Per the customer, the hospital and department has done their own investigation and determined it was human error.The customer states they do not need any retraining.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.Terumo bct service technician checked out the machine at the customer site.The machine completed all functional testing without any alarms or failures occurring.Machine operations were verified.Correction: terumo bct clinical support offered the customer retraining for the operator clamping error.The customer declined the retraining since they had already addressed the operator error internally.Root cause: based on the customer's description and dlog analysis, the operator had inadvertently left the return saline roller clamp open and the return pinch clamp closed.All of the replacement fluids were diverted into the saline bag via the open return saline roller while the return clamp remained closed.Therefore, the root cause was determined to be operator error.

• 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: 13600617
• MDR Text Key: 286160414
• Report Number: 1722028-2022-00062
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 35020583122209
• UDI-Public: 35020583122209
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/25/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2023
• Device Model Number: 12220
• Device Catalogue Number: 12220
• Device Lot Number: 2112093130
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 02/25/2022
• Supplement Dates Manufacturer Received: 09/13/2022; 11/01/2022; 01/20/2023
• Supplement Dates FDA Received: 10/03/2022; 11/22/2022; 02/03/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/09/2021
• 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; Required Intervention
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Weight: 101 KG