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

Catalog Number 10315

Device Problems Infusion or Flow Problem (2964); No Apparent Adverse Event (3189); Air/Gas in Device (4062)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that during a continuous mononuclear cell (cmnc) collection procedure they experienced a "patient's fluid balance may be 30% higher than reported" alarm.The only option was to disconnect the patient.There were few low flow alarms and there was air near the inlet pressure sensor.Patient id, age, gender and outcome are not available at this time.The disposables set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Event Description

The customer reported that during a continuous mononuclear cell (cmnc) collection procedure they experienced a "patient's fluid balance may be 30% higher than reported" alarm.The only option was to disconnect the patient.There were few low flow alarms and there was air near the inlet pressure sensor.Patient id, age, gender and outcome are not available at this time.The disposables set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: 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.The customer provided several photographs of the reported issue in lieu of the disposable set return.Photos one and two show a cascade of alerts relating to pressure, fluid detection and fluid balance issues.Photo 3 confirms the occurrence of clotting in the cassette reservoir and flow pathway, with evidence of foam in the inlet line trap.Photo four displays the run ending alarm relating to fluid balance being less than 30%.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h6 and h10.Investigation: 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.The customer provided several photographs of the reported issue in lieu of the disposable set return.Photos one and two show a cascade of alerts relating to pressure, fluid detection and fluid balance issues.Photo 3 confirms the occurrence of clotting in the cassette reservoir and flow pathway, with evidence of foam in the inlet line trap.Photo four displays the run ending alarm relating to fluid balance being less than 30%.The run data file (rdf) was analyzed for this event.Review of the rdf and aim images suggest that the cause for the multiple occurrences of the ¿patient's fluid balance may be lower than reported¿ alarms were due to an obstruction or restriction in the patient inlet line or possibly the connector towards the end of the run likely caused by clotting.At 217 minutes into the run, the ¿patient's fluid balance may be 10% lower than reported¿ alarm was generated.At 227 minutes, the ¿patient's fluid balance may be 20% lower than reported¿ and ¿low-level reservoir sensor did not detect fluid¿ alarms occurred.At 235 minutes, the third and final fluid balance alarm, ¿patient's fluid balance may be 30% lower than reported¿ occurred.The operator then had to end the procedure.Review of the aim images indicated some minor clotting in the collect connector towards the end of the procedure.If the inlet line flow is restricted or the inlet line trap develops an obstruction or partial occlusion from a skin plug, clot or other source, or the clotting cascades to the connector blocking fluid from exiting the passive rbc port, this can cause the inlet line to draw less fluid into the system or stop drawing entirely.With less fluid exiting the channel via the passive rbc line, there is less fluid being returned to the reservoir than the system expects which can result in reservoir sensor alarms and further fluid balance alarms as seen during the run.Signals from the level sensors in the reservoir also confirmed that fluid was not entering the reservoir as expected in the last 30 minutes of the procedure.Based on the values on the end of run screen, the final fluid balance was as follows: patient tbv: 948ml and reported fluid balance: +139ml % fluid balance = ((948 ml + 139 ml) / 948 ml) x 100 = 114% worst case adjusted final fluid balance = 114% - 30% = 84% further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.No further reporting will be provided as this does not represent a reportable event.

Event Description

The customer reported that during a continuous mononuclear cell (cmnc) collection procedure they experienced a "patient's fluid balance may be 30% higher than reported" alarm.The only option was to disconnect the patient.There were few low flow alarms and there was air near the inlet pressure sensor.Patient id and age are not available from the customer.The disposables set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

• 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: 12288003
• MDR Text Key: 267238065
• Report Number: 1722028-2021-00261
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 08/06/2021

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: 09/01/2022
• Device Catalogue Number: 10315
• Device Lot Number: 2009013130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 08/06/2021
• Supplement Dates Manufacturer Received: 10/28/2022; 11/30/2022
• Supplement Dates FDA Received: 11/07/2022; 12/01/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2020
• 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): Required Intervention
• Patient Sex: Female
• Patient Weight: 13 KG