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

Model Number 10220

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190); Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2022

Event Type  malfunction  

Manufacturer Narrative

Lot number, manufacture and expiry dates are not available at this time.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that they inadvertently entered the wrong weight of the patient for a red blood cell exchange procedure.The incorrect weight of 195 kg was entered.The patient actual weight was 95 kg.They had replaced 279ml saline and removed 375ml blood.The machine said the current hct was 26%.The customer disconnected the patient and started over with another set.The customer declined to provide the patient identifier.The patient is in stable condition.The customer is unable to return the exchange set because it was discarded.

Event Description

The customer reported that they inadvertently entered the wrong weight of the patient for a red blood cell exchange procedure.The incorrect weight of 195 kg was entered.The patient actual weight was 95 kg.They had replaced 279ml saline and removed 375ml blood.The machine said the current hct was 26%.The customer disconnected the patient and started over with another set.The customer declined to provide the patient identifier.The patient is in stable condition.The customer is unable to return the exchange set because it was discarded.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: the lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.The customer submitted six photographs in lieu of the disposable set to aid investigation.The images show the run screen and the data run values screen.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

Investigation: the lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that they inadvertently entered the wrong weight of the patient for a red blood cell exchange procedure.The incorrect weight of 195 kg was entered.The patient actual weight was 95 kg.They had replaced 279ml saline and removed 375ml blood.The machine said the current hct was 26%.The customer disconnected the patient and started over with another set.The customer declined to provide the patient identifier.The patient is in stable condition.The customer is unable to return the exchange set because it was discarded.

Event Description

The customer reported that they inadvertently entered the wrong weight of the patient for a red blood cell exchange procedure.The incorrect weight of 195 kg was entered.The patient actual weight was 95 kg.They had replaced 279ml saline and removed 375ml blood.The machine said the current hct was 26%.The customer disconnected the patient and started over with another set.The customer declined to provide the patient identifier.The patient is in stable condition.The customer is unable to return the exchange set because it was discarded.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: the lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.The customer submitted six photographs in lieu of the disposable set to aid investigation.The images show the run screen and the data run values screen.The run data file (rdf) was analyzed for this event.Review of the relevant rdf confirms the operator incorrectly input a patient weight of 195 kg and started the procedure.The operator stopped the procedure 11 minutes after the start and restarted with the proper patient weight.Optia uses the sex, height, and weight values input to calculate the patient¿s tbv.Inputting the incorrect patient weight in an rbcx procedure will lead to an incorrect calculation of the patient tbv which will affect the performance of the procedure.An incorrect tbv calculation will affect: - the set ac dose (aka maximum ac infusion rate), since it is based on tbv of patient (ml/min/l tbv), possibly delivering a higher than intended ac dose and can pose a safety risk to the patient - the reported fraction of original cells remaining (focr).If the operator set a target focr (ex 0.3) the system will overshoot the target by processing more cells than intended since it is using an oversized model of the patient to estimate the cell removal.- the estimated fluid balance percentage.The fluid balance will be based on an oversized model of the patient.This will cause inaccurate fluid balance estimates.Overall, it is important for the operator to enter accurate day-of patient information for best procedural performance.In this case it appears the operator unintentionally input the incorrect weight of 195kg and not the actual weight of 95kg in the first procedure analyzed.The operator quickly realized this error and corrected it by restarting the procedure with the correct patient information investigation is in process.A follow up report will be provided.

Manufacturer Narrative

Investigation: the lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.The customer submitted six photographs in lieu of the disposable set to aid investigation.The images show the run screen and the data run values screen.The run data file (rdf) was analyzed for this event.Review of the relevant rdf confirms the operator incorrectly input a patient weight of 195 kg and started the procedure.The operator stopped the procedure 11 minutes after the start and restarted with the proper patient weight.Optia uses the sex, height, and weight values input to calculate the patient¿s tbv.Inputting the incorrect patient weight in an rbcx procedure will lead to an incorrect calculation of the patient tbv which will affect the performance of the procedure.An incorrect tbv calculation will affect: the set ac dose (aka maximum ac infusion rate), since it is based on tbv of patient (ml/min/l tbv), possibly delivering a higher than intended ac dose and can pose a safety risk to the patient - the reported fraction of original cells remaining (focr).If the operator set a target focr (ex 0.3) the system will overshoot the target by processing more cells than intended since it is using an oversized model of the patient to estimate the cell removal.The estimated fluid balance percentage.The fluid balance will be based on an oversized model of the patient.This will cause inaccurate fluid balance estimates.Overall, it is important for the operator to enter accurate day-of patient information for best procedural performance.In this case it appears the operator unintentionally input the incorrect weight of 195kg and not the actual weight of 95kg in the first procedure analyzed.The operator quickly realized this error and corrected it by restarting the procedure with the correct patient information root cause: a root cause assessment was performed for this complaint.The root cause was determined to be due to a user data entry error where they entered the incorrect patient weight.

Event Description

The customer reported that they inadvertently entered the wrong weight of the patient for a red blood cell exchange procedure.The incorrect weight of 195 kg was entered.The patient actual weight was 95 kg.They had replaced 279ml saline and removed 375ml blood.The machine said the current hct was 26%.The customer disconnected the patient and started over with another set.The customer declined to provide the patient identifier.The patient is in stable condition.The customer is unable to return the exchange set because it was discarded.

• 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: 15191802
• MDR Text Key: 304885682
• Report Number: 1722028-2022-00258
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/09/2022

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
• Device Operator: Health Professional
• Device Model Number: 10220
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2022
• Initial Date FDA Received: 08/09/2022
• Supplement Dates Manufacturer Received: 11/30/2022; 12/14/2022; 04/12/2023; 06/06/2023
• Supplement Dates FDA Received: 12/05/2022; 12/27/2022; 04/28/2023; 06/13/2023
• 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: 32 YR
• Patient Sex: Male
• Patient Weight: 95 KG