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

Model Number 12320

Device Problems Use of Device Problem (1670); Output Problem (3005)

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

Event Date 05/08/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that they were doing a continuous mononuclear cell (cmnc) collection procedure and the following day after the procedure, they noticed the wring weight was entered prior to the procedure.During the procedure the mid ionized calcium came back at 3.6 from initial 4.6 (no symptoms noted), so they increased the calcium gluconate that was already running at 100 ml/hr to 120 ml/hr and then 150 ml/hr.Tums 1500 mg (500 mg x 3).The procedure was paused 3x for a few minutes each.Physician was not notified and it was part of a planned protocol.There were no issues noted during the procedure.There were no patient reactions reported and the patient is stable.Weight entered: 128kg.Actual weight: 128lb.Tbv was calculated by system at 5877ml.Actual tbv was 3.5 liters.The device is not available for return because it was discarded by the customer.

Event Description

The customer reported that they were doing a continuous mononuclear cell (cmnc) collection procedure and the following day after the procedure, they noticed the wring weight was entered prior to the procedure.During the procedure the mid ionized calcium came back at 3.6 from initial 4.6 (no symptoms noted), so they increased the calcium gluconate that was already running at 100 ml/hr to 120 ml/hr and then 150 ml/hr.Tums 1500 mg (500 mg x 3).The procedure was paused 3x for a few minutes each.Physician was not notified and it was part of a planned protocol.There were no issues noted during the procedure.There were no patient reactions reported and the patient is stable.Weight entered: 128kg.Actual weight: 128lb.Tbv was calculated by system at 5877ml.Actual tbv was 3.5 liters.The device 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: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in b.6, h.6 and h.10.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Correction: tbct clinical support performed retraining by explaining the effect of switching the units of measure of weights and how important it is to have the correct unit of measure so the weight is correct for the tbv calculation.Root cause: the root cause of the possible ac over infusion was determined to be due to an operator error where they entered the incorrect patient weight in the system.

Event Description

The customer reported that they performed a cmnc procedure and noticed they entered the wrong weight.Per the customer, calcium gluconate that was already running at 100 ml/hr to 120 ml/hr and then 150 ml/hr.Tums 1500 mg (500 mg x 3) as part of a planned protocol.There were no patient symptoms were noted and no unplanned medical intervention was required.The customer described the patient status as stable with a presenting diagnosis of multiple myeloma.No medications or treatments were administered prior to the procedure.128 kg was input and the actual weight was 128 lbs.Tbv was calculated at 5877 and the actual tbv was 3.5 liters.Terumo bct customer service informed the customer that the ac infusion rate is calculated with the tbv and this wouldn't have been accurate during the run.

• 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: 14574078
• MDR Text Key: 301030150
• Report Number: 1722028-2022-00171
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• 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
• Report Date: 06/02/2022

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 Expiration Date: 02/01/2024
• Device Model Number: 12320
• Device Catalogue Number: 12320
• Device Lot Number: 2202013230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 06/02/2022
• Supplement Dates Manufacturer Received: 11/28/2022; 02/27/2023
• Supplement Dates FDA Received: 12/13/2022; 03/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/02/2022
• 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: 60 YR
• Patient Sex: Female