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

Model Number 12320

Device Problems Use of Device Problem (1670); Infusion or Flow Problem (2964)

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

Event Date 04/04/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that normal saline line was noted to be infusing at a fast rate once the start run button was initiated for an apheresis stem cell collection procedure.The normal saline continued to infuse to patient despite the roller clamp being in the closed position and the blue clamp closed on the return line.The patient received approximately 250-300 mls.A kelly clamp was applied to the saline line, no further saline was noted to be dripping for the remainder of the procedure.The kelly clamp was removed at rinse back, and a high flow rate of saline was noted to be infusing again.Manual manipulation of the saline line was performed to control the rate of saline used for rinseback.The patient tolerated remainder of procedure.Patient information is not available at this time.Terumo bct is awaiting the return of the set.

Manufacturer Narrative

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

Event Description

The customer reported that normal saline line was noted to be infusing at a fast rate once the start run button was initiated for an apheresis stem cell collection procedure.The normal saline continued to infuse to patient despite the roller clamp being in the closed position and the blue clamp closed on the return line.The patient received approximately 250-300 mls.A kelly clamp was applied to the saline line, no further saline was noted to be dripping for the remainder of the procedure.The kelly clamp was removed at rinse back, and a high flow rate of saline was noted to be infusing again.Manual manipulation of the saline line was performed to control the rate of saline used for rinseback.The final reported fluid balance was 127%.The patient tolerated remainder of procedure.Patient gender is not available at this time.Terumo bct is awaiting the return of the set.

Event Description

The customer reported that normal saline line was noted to be infusing at a fast rate once the start run button was initiated for an apheresis stem cell collection procedure.The normal saline continued to infuse to patient despite the roller clamp being in the closed position and the blue clamp closed on the return line.The patient received approximately 250-300 mls.A kelly clamp was applied to the saline line, no further saline was noted to be dripping for the remainder of the procedure.The kelly clamp was removed at rinse back, and a high flow rate of saline was noted to be infusing again.Manual manipulation of the saline line was performed to control the rate of saline used for rinseback.The final reported fluid balance was 127%.The patient tolerated remainder of procedure.Patient gender is not available at this time.

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 bag was attached to the saline and spike.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.All witness and wear marks indicate individual loop and channel components were properly loaded.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 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 bag was attached to the saline and spike.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.All witness and wear marks indicate individual loop and channel components were properly loaded.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 normal saline line was noted to be infusing at a fast rate once the start run button was initiated for an apheresis stem cell collection procedure.The normal saline continued to infuse to patient despite the roller clamp being in the closed position and the blue clamp closed on the return line.The patient received approximately 250-300 mls.A kelly clamp was applied to the saline line, no further saline was noted to be dripping for the remainder of the procedure.The kelly clamp was removed at rinse back, and a high flow rate of saline was noted to be infusing again.Manual manipulation of the saline line was performed to control the rate of saline used for rinseback.The final reported fluid balance was 127%.The patient tolerated remainder of procedure.Patient gender is not available at this time.

Manufacturer Narrative

This report is being filed to provide additional information in 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 bag was attached to the saline and spike.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.All witness and wear marks indicate individual loop and channel components were properly loaded.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 the inlet and/or return saline roller clamp.

Event Description

The customer reported that normal saline line was noted to be infusing at a fast rate once the start run button was initiated for an apheresis stem cell collection procedure.The normal saline continued to infuse to patient despite the roller clamp being in the closed position and the blue clamp closed on the return line.The patient received approximately 250-300 mls.A kelly clamp was applied to the saline line, no further saline was noted to be dripping for the remainder of the procedure.The kelly clamp was removed at rinse back, and a high flow rate of saline was noted to be infusing again.Manual manipulation of the saline line was performed to control the rate of saline used for rinseback.The final reported fluid balance was 127%.The patient tolerated remainder of procedure.

• 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: 14398343
• MDR Text Key: 300142889
• Report Number: 1722028-2022-00153
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/13/2022

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 05/13/2022
• Supplement Dates Manufacturer Received: 09/20/2022; 09/20/2022; 09/20/2022; 09/20/2022
• Supplement Dates FDA Received: 06/07/2022; 06/30/2022; 09/09/2022; 09/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 109 KG