MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA IDL SET FOR BMP WITH CORRECT CONNECT

Model Number 12320

Device Problems Excess Flow or Over-Infusion (1311); Unexpected Therapeutic Results (1631); Use of Device Problem (1670); Human-Device Interface Problem (2949); Device Handling Problem (3265)

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

Event Date 04/06/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that a stem collection was initiated and at approximately 1200cc the machine alarmed that it was taking too long to establish interface.The first suggestion on the alarm screen was to adjust the hematocrit so they reduced it.They then noticed that the normal saline (ns) bag had almost completely infused (approximately 750cc) despite both the roller clamp and the saline blue pinch clamp on the return were both in the closed position.They put a kelly clamp on the ns line to stop the flow and then on rinse back, a fast flow of saline was noted after removing the kelly clamp, so manual manipulation was preformed to the ns line to reduce the drip rate.Per the customer, the patient received approximately 250-300 mls.The patient was notified of the extra ns infused.No complications were noted and no medical intervention was required.Terumo bct is awaiting the return of the disposable set.

Event Description

The customer reported that a stem collection was initiated and at approximately 1200cc the machine alarmed that it was taking too long to establish interface.The first suggestion on the alarm screen was to adjust the hematocrit so they reduced it.They then noticed that the normal saline (ns) bag had almost completely infused (approximately 750cc) despite both the roller clamp and the saline blue pinch clamp on the return were both in the closed position.They put a kelly clamp on the ns line to stop the flow and then on rinse back, a fast flow of saline was noted after removing the kelly clamp, so manual manipulation was preformed to the ns line to reduce the drip rate.Per the customer, the patient received approximately 250-300 mls.The patient was notified of the extra ns infused.No complications were noted and no medical intervention was required.Terumo bct is awaiting the return of the disposable set.

Manufacturer Narrative

This report is being filed to provide additional information in h.3, h.6 and h.10.Investigation: a used optia set containing blood was returned for investigation.It was noted that blood had circulated throughout the set.Additionally, blood warmer tubing was attached to the return coil.Furthermore, the saline and ac bags were attached to the saline and ac spikes.The disposable set was visually evaluated for any mis-assembly, leak location, or defect that could have contributed to the reported incident with no anomalies observed.Witness and wear marks on the loop and channel components were inspected for evidence of proper loading.Marks on the lower hex indicate the lower hex was loaded in a non-optimal position where occlusions in the 4-lumen tubing could result.No other anomalies were noted.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in a.1, a.3, h.6 and h.10.Investigation: a used optia set containing blood was returned for investigation.It was noted that blood had circulated throughout the set.Additionally, blood warmer tubing was attached to the return coil.Furthermore, the saline and ac bags were attached to the saline and ac spikes.The disposable set was visually evaluated for any mis-assembly, leak location, or defect that could have contributed to the reported incident with no anomalies observed.Witness and wear marks on the loop and channel components were inspected for evidence of proper loading.Marks on the lower hex indicate the lower hex was loaded in a non-optimal position where occlusions in the 4-lumen tubing could result.No other anomalies were noted.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 a stem collection was initiated and at approximately 1200cc the machine alarmed that it was taking too long to establish interface.The first suggestion on the alarm screen was to adjust the hematocrit so they reduced it.They then noticed that the normal saline (ns) bag had almost completely infused (approximately 750cc) despite both the roller clamp and the saline blue pinch clamp on the return were both in the closed position.They put a kelly clamp on the ns line to stop the flow and then on rinse back, a fast flow of saline was noted after removing the kelly clamp, so manual manipulation was preformed to the ns line to reduce the drip rate.Per the customer, the patient received approximately 250-300 mls.The patient was notified of the extra ns infused.No complications were noted and no medical intervention was required.

Manufacturer Narrative

Investigation: a used optia set containing blood was returned for investigation.It was noted that blood had circulated throughout the set.Additionally, blood warmer tubing was attached to the return coil.Furthermore, the saline and ac bags were attached to the saline and ac spikes.The disposable set was visually evaluated for any mis-assembly, leak location, or defect that could have contributed to the reported incident with no anomalies observed.Witness and wear marks on the loop and channel components were inspected for evidence of proper loading.Marks on the lower hex indicate the lower hex was loaded in a non-optimal position where occlusions in the 4-lumen tubing could result.No other anomalies were noted.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: terumo bct has offered customer retraining for this issue.The regional clinical specialist confirmed that the retraining was declined as not needed since the issue did not recur since april.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be a failure of the operator to adequately close either the inlet and/or return saline roller clamp.

Event Description

The customer reported that a stem collection was initiated and at approximately 1200cc the machine alarmed that it was taking too long to establish interface.The first suggestion on the alarm screen was to adjust the hematocrit so they reduced it.They then noticed that the normal saline (ns) bag had almost completely infused (approximately 750cc) despite both the roller clamp and the saline blue pinch clamp on the return were both in the closed position.They put a kelly clamp on the ns line to stop the flow and then on rinse back, a fast flow of saline was noted after removing the kelly clamp, so manual manipulation was preformed to the ns line to reduce the drip rate.Per the customer, the patient received approximately 250-300 mls.The patient was notified of the extra ns infused.No complications were noted and no medical intervention was required.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET FOR BMP WITH CORRECT CONNECT
• 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: 14279934
• MDR Text Key: 299460650
• Report Number: 1722028-2022-00144
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/03/2022

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: 02/01/2024
• Device Model Number: 12320
• Device Catalogue Number: 12320
• Device Lot Number: 2202013230
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2022
• Initial Date FDA Received: 05/04/2022
• Supplement Dates Manufacturer Received: 09/20/2022; 09/20/2022; 09/20/2022
• Supplement Dates FDA Received: 06/20/2022; 09/02/2022; 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 25 YR
• Patient Sex: Female
• Patient Weight: 61 KG