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

Catalog Number 10223

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/03/2021

Event Type  Injury  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during the set-up of a red blood cell exchange (rbcx) procedure, the nurse connected the anticoagulant citrate dextrose solution a (acd-a) bag with the saline line and the saline bag with the acd-a line.After 5 of 7 blood bag she discovered the mistake.Per the customer the physician stopped the procedure and the patient was transferred to icu.The patient remained under surveillance until saturday morning and then went home with no injury.Patient information is unknown at this time.The collection set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

Investigation: per follow up with the customer, there were no clots in the circuit and there were no pressure alarms during the procedure.Correction: retraining was done on (b)(6) after the incident.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during the set-up of a red blood cell exchange (rbcx) procedure, the nurse connected the anticoagulant citrate dextrose solution a (acd-a) bag with the saline line and the saline bag with the acd-a line.After 5 of 7 blood bag she discovered the mistake.Per the customer the physician stopped the procedure and the patient was transferred to icu.The patient remained under surveillance until saturday morning and then went home with no injury.The collection set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Corrected information is provided in b.3.Investigation: per follow up with the customer, there were no clots in the circuit and there were no pressure alarms during the procedure.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Correction: retraining was done on tuesday, september 7th after the incident.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during the set-up of a red blood cell exchange (rbcx) procedure, the nurse connected the anticoagulant citrate dextrose solution a (acd-a) bag with the saline line and the saline bag with the acd-a line.After 5 of 7 blood bag she discovered the mistake.Per the customer the physician stopped the procedure and the patient was transferred to icu.The patient remained under surveillance until saturday morning and then went home with no injury.The collection set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Event Description

The customer reported that during the set-up of a red blood cell exchange (rbcx) procedure, the nurse connected the anticoagulant citrate dextrose solution a (acd-a) bag with the saline line and the saline bag with the acd-a line.After 5 of 7 blood bag she discovered the mistake.Per the customer the physician stopped the procedure and the patient was transferred to icu.The patient remained under surveillance until saturday morning and then went home with no injury.The collection set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: per follow up with the customer, there were no clots in the circuit and there were no pressure alarms during the procedure.An investigation was conducted for an incident where the patient received a bolus of acd-a and was admitted to icu for observations.The operator had connected the acd-a bag to the saline line and a 1000 ml saline bag to the ac line during an rbcx procedure.As a result of this error, the system had used acd-a to prime the set during saline prime.The end of run screen displayed saline volume used as 259 ml including 40 ml prime diverted up into the waste bag.Therefore, the patient received an unintended bolus of 219 ml of acd-a in addition to the acd-a in the replacement rbc units.According to the customers sop one operator sets up the disposable set and another colleague verifies the connections right before a procedure.However, the team was completely busy on this day so one operator did the set-up, another operator primed the set, and a third operator started the procedure.They do not use disposable sets with correct connect configuration.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A photograph was submitted in lieu of the disposables set to aid in the investigation.The picture shows an unused 500 ml 0.9% saline bag hung on an iv pole.The picture did not show the switched ac and saline bags that were connected to the machine.A disposable complaint history search was performed for this lot and found no other reports for similar issues on this lot.Correction: retraining was done on tuesday, september 7th after the incident.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: per follow up with the customer, there were no clots in the circuit and there were no pressure alarms during the procedure.According to the customers sop one operator sets up the disposable set and another colleague verifies the connections right before a procedure.However, the team was completely busy on this day so one operator did the set-up, another operator primed the set, and a third operator started the procedure.They do not use disposable sets with correct connect configuration.The run data file (rdf) was analyzed for this event.The customer reported the operator had connected the acd-a bag to the saline line and a 1-l saline bag to the ac line during a red blood cell exchange/depletion (rbcx-d) procedure.¿as a result of this error, the system used acd-a to prime the set instead of saline during the priming sequence.Review of the run data file confirmed the saline volume returned to patient post-connection was 39.62mls (channel fluid saline volume + reservoir fluid saline volume ¿ remove bag saline volume).Therefore, the patient received an unintended bolus of 40ml of acd-a in addition to the acd-a in the replacement saline/albumin fluid (4% citrate) during the initial few minutes of the depletion portion of the rbcx-d procedure.At 85 minutes into the procedure, the operator paused then ended the run with no rinseback.Per terumobct internal medical review conclusion, the use error of connecting the acd-a bag to the saline line during the set-up of the spectra optia device accounted for the adverse event reported in this complaint that necessitated monitoring of the patient in an icu setting.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A photograph was submitted in lieu of the disposables set to aid in the investigation.The picture shows an unused 500 ml 0.9% saline bag hung on an iv pole.The picture did not show the switched ac and saline bags that were connected to the machine.A disposable complaint history search was performed for this lot and found no other reports for similar issues on this lot.Correction: retraining was done on tuesday, september 7th after the incident.Root cause: the root cause was determined to be an operator error where the saline and acd-a bags were switched.

Event Description

An investigation was conducted for an incident where the patient received a bolus of acd-a and was admitted to icu for observations.The operator had connected the acd-a bag to the saline line and a 1000 ml saline bag to the ac line during an rbcx procedure.As a result of this error, the system had used acd-a to prime the set during saline prime.The end of run screen displayed saline volume used as 259 ml including 40 ml prime diverted up into the waste bag.Therefore, the patient received an unintended bolus of 219 ml of acd-a in addition to the acd-a in the replacement rbc units.The customer stated that only one saline bag was used for the entire procedure.There were no pressure alarms or clotting in the set.The hematocrit of the replacement fluids was 56%.The operator discovered the error after five of the seven replacement blood bags were used.The physician stopped the procedure, and the patient received 2 ampoules of calcium gluconate right after the procedure.He was later transferred to icu the following day on 4 sep 2021.The patient remained under surveillance until morning of 6 sep 2021, and then went home with no injury.The collection set is not available for return because it was discarded by the customer.Due to eu personal data protection laws, the patient information is not available from the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

• 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: 12547980
• MDR Text Key: 273827235
• Report Number: 1722028-2021-00310
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Catalogue Number: 10223
• Device Lot Number: 2105113230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/17/2021
• 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: 42 YR
• Patient Sex: Male
• Patient Weight: 84 KG