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

Model Number 12320

Device Problems Excess Flow or Over-Infusion (1311); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Numbness (2415)

Event Date 01/25/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation: final fluid balance calculation (fb): 4863 + 1200 mls + 1933=7996 ml/4863 ml=1.64 x 100=164%.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that approximately 30 minutes into a continuous mononuclear cell (cmnc) collection they were not able to establish interface.There was about 700 mls of normal saline (ns) missing from a 1 liter bag.Terumo bct customer support inquired during a call with the customer what the status of the clamps were; the blue roller clamp was closed and the red roller clamp was still open.The operator closed the clamp and the ns stopped dripping.Per follow up with the customer the final fluid balance was 140%.The patient received iv calcium gluconate in approximately 500 ml of ns, per protocol.Patient was allowed to drink and had sprite and orange juice.The patient did well.Mild numbness and tingling around lips and hands and had a normal sinus rhythm in ekg strip.Patient identifier and age are unknown at this time.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 a.Investigation: final fluid balance calculation (fb): 44863 ml+ 700 ml + 1933ml=7496 ml/4863 ml=1.54 x 100=154%.Photographs of the end run screens were provided and indicated that the final fluid balance from the machine was 1933 ml (140%).A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Correction: the customer was offered retraining but declined on the grounds that the staff is able to identify and troubleshoot when a clamp is open.Root cause: a root cause assessment was performed for the unintended saline bolus to the patient.Based on the clinical findings, the operator failed to follow the screen prompt to fully close the (red) inlet saline roller clamp at the end of prime divert.A root cause assessment was performed for the reported citrate reaction.These types of reactions occur due to decreased ionized calcium in circulation as a result of exogenous citrate administered during the apheresis procedure and are influenced by donor physiology, the rate of ac infusion, and/or the length of the procedure.These symptoms may be treated with oral or intravenous calcium supplements or by adjusting the ac infusion rate.

Event Description

The customer reported that approximately 30 minutes into a continuous mononuclear cell (cmnc) collection they were not able to establish interface.There was about 700 mls of normal saline (ns) missing from a 1 liter bag.Terumo bct customer support inquired during a call with the customer what the status of the clamps were; the blue roller clamp was closed and the red roller clamp was still open.The operator closed the clamp and the ns stopped dripping.Per follow up with the customer the final fluid balance was 140%.The patient received iv calcium gluconate in approximately 500 ml of ns, per protocol.Patient was allowed to drink and had sprite and orange juice.The patient did well.Mild numbness and tingling around lips and hands and had a normal sinus rhythm in ekg strip.Medical intervention was not performed as the patient tolerated the procedure well.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: final fluid balance calculation (fb): 44863 ml+ 700 ml + 1933ml=7496 ml/4863 ml=1.54 x 100=154%.Photographs of the end run screens were provided and indicated that the final fluid balance from the machine was 1933 ml (140%).A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.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.

Event Description

The customer reported that approximately 30 minutes into a continuous mononuclear cell (cmnc) collection they were not able to establish interface.There was about 700 mls of normal saline (ns) missing from a 1 liter bag.Terumo bct customer support inquired during a call with the customer what the status of the clamps were; the blue roller clamp was closed and the red roller clamp was still open.The operator closed the clamp and the ns stopped dripping.Per follow up with the customer the final fluid balance was 140%.The patient received iv calcium gluconate in approximately 500 ml of ns, per protocol.Patient was allowed to drink and had sprite and orange juice.The patient did well.Mild numbness and tingling around lips and hands and had a normal sinus rhythm in ekg strip.Patient identifier and age are unknown at this time.The collection set is not available for return because it was discarded by the customer.

• 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: 13560325
• MDR Text Key: 288609783
• Report Number: 1722028-2022-00053
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2022

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: 08/01/2023
• Device Model Number: 12320
• Device Catalogue Number: 12320
• Device Lot Number: 2108043230
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/18/2022
• Supplement Dates Manufacturer Received: 02/20/2023; 03/21/2023
• Supplement Dates FDA Received: 03/09/2023; 03/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/09/2021
• 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
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 86 KG