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

Catalog Number 10120

Device Problems Complete Blockage (1094); Low Test Results (2458); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information: (b)(6) investigation: per customer follow up, it was found that the saline rolling clamps were on the correct lines and properly connected.A used spectra optia set was returned for investigation.Upon visual inspection, it was noted that the set was assembled correctly with no kinks, leaks, occlusions or missing parts.Flow of blood was observed throughout the set and in the inlet line, cassette and in the channel.The set was successfully flow tested by passing fluid through the inlet line.There was evidence of clotting in the inlet line trap and in the channel connector.No disposable defects were identified.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported while performing an apheresis procedure on a spectra optia device with a pediatric patient with myelodysplastic syndromes (mds), they received the alarm 'patient's fluid balance may be 30% lower than reported' and the customer noticed blockage in the inlet line.The operator stopped the procedure and disconnected the patient.It is unknown at this time if any medical intervention was required for this event.The information for the investigation such as procedural details is not available at this time.Due to eu personal data protection laws, the patient information/patient outcome is not available from the customer.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.The signals in the rdf indicate that the spectra optia system operated as intended.Review of the rdf and aim images suggest that the likely cause for the multiple occurrences of the ¿patient's fluid balance may be lower than reported¿ alarms were likely due to an obstruction or restriction in the patient inlet line possibly caused by clotting.Shortly after the procedure was started, there were numerous inlet and return pressure alarms (x16 inlet, x9 return) followed by the ¿patient's fluid balance may be 10% lower than reported¿ and ¿low-level reservoir sensor did not detect fluid¿ alarms.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, 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.At 40 minutes, the operator ended the run after the third alarm, ¿patient's fluid balance may be 30% lower than reported¿, occurred.There were several ¿low-level reservoir sensor did not detect fluid¿ alarms which occur if the system detected air at the lower level sensor before 25ml were pumped by the return pump as a result of less fluid going to the reservoir.As mentioned previously, this may be caused due to clotting since clotting can cause restrictions in the flow and lead to flow discrepancies that cause level sensor alarms.Review of the aim images did confirm the presence of clotting in the collect connector very early in the procedure.Additionally, when the pumps have been paused for an extended period of time, the system alarms with the ¿pumps have been paused for 3 minutes¿ and the ¿pumps have been paused for 10 minutes.These alarms are intended to inform the operator that a saline drip should be started to keep the inlet line from clotting.The three-minute alarm informs the operator that a saline drip should be started, and the ten-minute alarm informs the operator that if a saline drip was not started, the operator should remove any obstructions from the inlet line and the return line.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Root cause: review of the dlog and aim images suggest that the likely cause for the multiple occurrences of the ¿patient's fluid balance may be lower than reported¿ alarms were likely due to an obstruction or restriction in the patient inlet line possibly caused by clotting.Shortly after the procedure was started, there were numerous inlet and return pressure alarms (x16 inlet, x9 return) followed by the ¿patient's fluid balance may be 10% lower than reported¿ and ¿low-level reservoir sensor did not detect fluid¿ alarms.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, 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.At 40 minutes, the operator ended the run after the third alarm, ¿patient's fluid balance may be 30% lower than reported¿, occurred.There were several ¿low-level reservoir sensor did not detect fluid¿ alarms which occur if the system detected air at the lower level sensor before 25ml were pumped by the return pump as a result of less fluid going to the reservoir.As mentioned previously, this may be caused due to clotting since clotting can cause restrictions in the flow and lead to flow discrepancies that cause level sensor alarms.Review of the aim images did confirm the presence of clotting in the collect connector very early in the procedure.Additionally, when the pumps have been paused for an extended period of time, the system alarms with the ¿pumps have been paused for 3 minutes¿ and the ¿pumps have been paused for 10 minutes.These alarms are intended to inform the operator that a saline drip should be started to keep the inlet line from clotting.The three-minute alarm informs the operator that a saline drip should be started, and the ten-minute alarm informs the operator that if a saline drip was not started, the operator should remove any obstructions from the inlet line and the return line.Possible root causes for clotting include but are not limited to:- improper anticoagulation of the extra corporeal system- patient¿s port was improperly flushed prior to the procedure resulting in clots being introduced into the set during the procedure- saline drip was not performed to maintain patency of the access when the procedure was paused for an extended period of time- patient¿s physiology or underlying disease state.

Event Description

The customer confirmed that no medical intervention was performed.Per the customer the procedure was discontinued after 41 minutes.No rinse back was performed during the collection.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 8565222
• MDR Text Key: 145094518
• Report Number: 1722028-2019-00100
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583101203
• UDI-Public: 05020583101203
• Combination Product (y/n): N
• 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
• Report Date: 04/30/2019

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: 07/01/2020
• Device Catalogue Number: 10120
• Device Lot Number: 1807103131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/05/2019
• Initial Date FDA Received: 04/30/2019
• Supplement Dates Manufacturer Received: 04/30/2019; 06/14/2019
• Supplement Dates FDA Received: 05/24/2019; 06/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2018
• 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: 00003 YR
• Patient Weight: 10