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

Catalog Number 10220

Device Problems Defective Alarm (1014); Excess Flow or Over-Infusion (1311); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypervolemia (2664); No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation: the rbcx disposable set was returned for evaluation.Upon visual inspection, it was confirmed the set was assembled correctly with no kinks, occlusions or missing parts.Flow of blood was observed throughout the set and in the inlet line, cassette and channel.The lower bearing was partially attached to the ears on the lower loop sleeve.One ear was detached with a residue of dried blood located around the 4-lumen tubing.Neither of the attachment ears were damaged.No leak could be identified upon leak testing and the blood was believed to come from uncapped inlet and return luers.No damage was observed on either luer connector.Inlet and return pinch clamps were present, closed and on correct tubing lines.The inlet and roller clamps were present and on the correct lines, however the return (blue) roller clamp was not fully closed.No disposable defects were identified.The run data file (rdf) was analyzed for this event.Signals in the rdf shown that the operator left both the inlet and return saline line roller clamps open during the procedure.This is evidenced by the pressure signals at both the inlet and return pressure sensors being almost identical, when normally the return signal is positive and the inlet is negative.With both roller clamps open, replacement fluid will be drawn from the return line into the return saline line,which will then be pulled into the inlet saline line and ultimately into the inlet line.This causes the pressure signals to be the same, as the inlet and return saline lines share a common pathway within the cassette.The interface aim images were reviewed and determined that the aim system appeared very bright and showed little-to-no visible interface for the first 40 minutes of the procedure.After this point, the interface was observed rising in the connector to the point that is typically seen during rbcx procedures.This demonstrates that saline was the primary fluid in the connector during this time and once the saline ran out, replacement rbcs were being pulled in through the inlet line.These observations further support the above suspicion that both saline line roller clamps were left open while the inlet pinch clamp remained closed/occluded.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is still in process.A follow-up report will be provided.

Event Description

The customer reported that during a red blood cell exchange (rbcx) procedure on a pediatric patient, the operator noticed that the saline bag was empty and no hemoglobins were observed in the waste bag.The customer stated that they received no alarms during the procedure.No medical intervention was required for this event.Patient identifier, age and outcome are not available at this time.

Manufacturer Narrative

Investigation: per the customer, the patient has a portacath, and have access issues that result in pressure alarms.During the procedure, there were no pressure alarms at a flowrate of 23 ml/min.The customer also stated that the patient's hemoglobin s (hbs), which is the marker for sickle cell, was 27% prior to the procedure, and dropped to 24% post procedure.However, the customer analysis on the waste bag showed zero hbs.Additionally, the patient hematocrit increased from 30.2% to 38.5%.The spectra optia contained with blood was returned for investigation.In addition to the return of the disposable set, a 500 ml acd-a bag, a 500 ml saline bag and two empty packed rbc bags were returned and attached to the set.The waste bag has not been removed from the set.A 50 ml aliquot was transferred from the rbc waste bag to a conical tube for further analysis.A complete blood count was performed on coulter hematology analyzer (n=2).A small sample was diluted with phosphate buffered saline and a wet mount was prepared.The slide was examined under microscope for cellular composition in the rbc waste bag.The results confirmed that majority of the red cells are biconcave disc with occasional drepanocytes (sickle cells) of less than 1%.Results indicated that some of patient's blood was present in the waste bag, and that the inlet clamp was open during the procedure.The returned waste bag was weighed as well as an empty bag.The waste bag's weight was calculated as 2592.8ml.Based on fda guidance, the specific gravity of rbc products with additive solution is 1.06 g/ml and without additive solution is 1.08 g/ml.Based on the rdf analysis, the patient total blood volume (tbv) was calculated to be 2577ml.The system also calculated the replacement and remove volumes as 2382 ml and 2754ml, respectively.The patient was set to 100% fluid balance, so the remaining 416 ml is comprised of acd-a.Based on the returned product, the saline volume is known to be 500ml.The volume returned to the patient was calculated to be 705 ml.The calculations align with the rdf analysis suspected that the patient would have been receiving return fluids during the first 40 minutes, which would equate to a maximum of 843 ml.Terumo bct has provided feedback to the customer regarding the incident and the customer acknowledged that they understood what happened during the procedure.Root cause: the original complaint description of no hbs in the remove bag, higher fcr remaining in the patient, the use of more saline than normal, and the lack of inlet pressure alarms can all be explained by the circulation of replacement rbcs and saline in place of the patient's blood due to the saline roller clamps being open both the access and return lines.The patient would have received some rbc replacement with only a small volume removed of their rbcs, thus increasing the hct and decreasing the percentage of hbs.This would mean that a majority of the fluids would have been returned to the patient during that first 40 minutes.However, once the saline ran out, little-to-no replacement fluid would have been returned as the inlet pump was drawing in the fluid as fast as the return pump was attempting to return it.This would have resulted in an increase of tbv to approximately 127%.Reference: (b)(6).Guidance for industry: recommendations for collecting red blood cells by automated apheresis methods.(b)(6).

Event Description

Due to eu personal data protection laws, the patient information is not available from the customer.

Manufacturer Narrative

This report is being filed to provide additional information.

Event Description

Further clarification was received from the customer.The customer stated that the patient's hematocrit and hemoglobin s (hbs) increased post procedure.The patient underwent a second red blood cell (rbcx) procedure to decrease the patient's hematocrit and hemoglobin s(hbs) levels to normal.

Manufacturer Narrative

This report is being filed to correct information.Root cause: the original complaint description of no hbs in the remove bag, higher fcr remaining in the patient, the use of more saline than normal, and the lack of inlet pressure alarms can all be explained by the circulation of replacement rbcs and saline in place of the patient's blood due to the saline roller clamps being open both the access and return lines.The patient would have received some rbc replacement with only a small volume removed of their rbcs, thus increasing the hct and decreasing the percentage of hbs.This would mean that a majority of the fluids would have been returned to the patient during that first 40 minutes.However, once the saline ran out, little-to-no replacement fluid would have been returned as the inlet pump was drawing in the fluid as fast as the return pump was attempting to return it.This would have resulted in an increase of tbv to approximately 121%.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6457690
• MDR Text Key: 72339070
• Report Number: 1722028-2017-00128
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K153601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/04/2017

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: 11/01/2018
• Device Catalogue Number: 10220
• Device Lot Number: 11Z3123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2017
• Initial Date FDA Received: 04/04/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 01/12/2018
• Supplement Dates FDA Received: 04/26/2017; 06/16/2017; 01/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2016
• 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 Weight: 32