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

Catalog Number 10220

Device Problems Air Leak (1008); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Inadequate User Interface (2958); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 10/19/2017

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer reported that during a therapeutic plasma exchange (tpe) procedure, they received an aim interface alarm.While troubleshooting, the operator noticed the saline bag was empty and observed air in the return line.The operator checked that the return saline roller clamp was closed.The operator disconnected the patient, hung a 2nd 500ml of saline bag, and checked that the return saline roller clamp was closed.The operator also removed air fromthe return line and the patient was re-connected.The procedure was continued with no alarms, however, the operator noticed the replacement fluid diverting back to the saline bag.The customer stated that the patient received approximately 650ml of saline and no medical intervention was required for this event.Serious injury and death was reported by the customer, however, clarification of the serious injury and death has not yet been provided.Patient information is not available at this time.The tpe disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: per the customer, the replacement fluid for this procedure was plasma,however, the spectra optia system used saline instead of plasma as replacement fluid and they did not receive any alarms.The run data file (rdf) was analyzed for the event on (b)(6) 2017.Review of the rdf confirmed the occurrence of the ¿low-level reservoir sensor detected air¿ and the ¿return pump did not stop¿ alarms.These alarms occur if the safety system has detected air at the lower level sensor for greater than 250 milliseconds.This alarm may occur for a number of reasons, including the blood was foamy, the centrifuge speed caused device to vibrate excessively, mismatched fpga between control and safety or a defective level sensor.In this particular procedure, although the safety system sees air, control does not see air at the lower level sensor.This alarm has been caused by mismatched fpgas on control and safety stacks.Rdf analysis confirmed that the machine alarmed as intended and the reported problem resulted in a failsafe condition.The run data file (rdf) was analyzed for the event on (b)(6) 2017.Review of the rdf does not show conclusive root cause for why saline was used as the replacement fluid instead of ffp.In the complaint the operator notes that after receiving an alarm about ¿replacement fluid was not detected¿ the operator noticed that saline was empty.The operator clamped the return line, however it was stated that when the return line was closed there were no alarms and the return fluid was entering the saline bag.If the return saline line was left open and the return line was closed then fluid would be returned up the saline line pumped by the return pump back into the saline bag.The operator then states that the operator reconnected the return line to the patient and the procedure was continued, however, instead of replacement fluid (ffp) being returned to the patient it was saline that was being returned to the patient.If the replacement fluid that was returned to the patient was saline instead of ffp, it is possible the operator accidentally connected saline to the replace line instead of the intended replacement fluid.There are two spikes on the replacement line, it may be possible that there was both saline and replacement fluid connected to the replace line and the operator closed the clamp that would allow replacement fluid in the replace line and opened the one that would allow saline in the replacement line.Another possibility is the operator left the inlet/return saline line open causing excess saline to be used.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that approximately 15 minutes into a therapeutic plasma exchange(tpe) procedure, they received a 'return pump was not stopped.Saline was not spread' alarm.The operator was unable to resolve the alarm at the time and the only option was to discontinue the procedure.A new tpe disposable set was setup on the same machine and the procedure was successfully completed.No medical intervention was required for this event.On the following day ((b)(6) 2017) the patient was undergoing another tpe procedure and they received an aim interface alarm.While troubleshooting, the operator noticed the saline bag was empty and observed air in the return line.The operator checked that the return saline roller clamp was closed.The operator disconnected the patient, hung a 2nd 500 ml of saline bag, and checked that the return saline roller clamp was closed.The operator also removed air from the return line and the patient was re-connected.The procedure was continued with no alarms, however, the operator noticed the replacement fluid diverting back to the saline bag.The customer stated that the patient received approximately 650 ml of saline and no medical intervention was required for this event.During customer follow-up, the customer stated that the patient expired on (b)(6) 2017 and the cause of death was due to progressive liver failure.The customer also indicated that only one patient was involved.Patient's gender and weight were obtained from the run data file (rdf).

Manufacturer Narrative

This report is being filed to provide additional information in describe event or problem.Investigation is in process.A follow-up report will be provided.

Event Description

The customer declined to provide additional procedural details, patient information and autopsy results for this event.

Manufacturer Narrative

This report is being filed.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Per the therapeutic apheresis: a physician's handbook, morbidity and mortality related to therapeutic procedures are greater in acutely ill patients.A review of one registry calculated an overall mortality between 1/10,000 and 2/10,0000 procedures.A patient's death during anapheresis series is most often attributed to the disease state and is rarely directly related to the procedure.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: the spectra optia apheresis essentials guide provides the following caution: "the physiological condition of patients may affect the outcomes of procedures performed on the spectra optia system."root cause: the definitive cause for the patient¿s death is undetermined but is not alleged to be due to the spectra optia system.Based on the nurse's description of events, dlog analysis, and machine service inspection, the likely root cause was the patient's disease state, but this could not be confirmed by the physician or with medical records.Root cause review of the dlog associated with this complaint confirms the occurrence of the ¿low-level reservoir sensor detected air¿ and the ¿return pump did not stop¿ alarms.These alarms occur if the safety system has detected air at the lower level sensor for greater than 250 milli seconds.This alarm may occur for a number of reasons, including: blood was foamy; centrifuge speed caused device to vibrate excessively; mismatched fpga between control and safety; defective level sensorin this particular procedure, although the safety system sees air, control does not see air at the lower level sensor.This alarm has been caused by mismatched fpgas on control and safety stacks.This condition is non-recoverable (fail safe).Root cause review of the dlog associated with this complaint does not show conclusive root cause for why saline was used as the replacement fluid instead of ffp.In the complaint the operator notes that after receiving an alarm about ¿replacement fluid was not detected¿ the operator noticed that saline was empty.The operator clamped the return line, however it was stated that when the return line was closed there were no alarms and the return fluid was entering the saline bag.If the return saline line was left open and the return line was closed then fluid would be returned up the saline line pumped by the return pump back into the saline bag.The operator then states that the operator reconnected the return line to the patient and the procedure was continued, however, instead of replacement fluid (ffp) being returned to the patient it was saline that was being returned to the patient.If the replacement fluid that was returned to the patient was saline instead of ffp, it is possible the operator accidentally connected saline to the replace line instead of the intended replacement fluid.There are two spikes on the replacement line, it may be possible that there was both saline and replacement fluid connected to the replace line and the operator closed the clamp that would allow replacement fluid in the replace line and opened the one that would allow saline in the replacement line.Another possibility is the operator left the inlet/return saline line open causing excess saline to be used.

Event Description

The customer did not respond to multiple attempts to obtain patient id, age and autopsy or discharge summary report.This report is being filed due to patient death, although per current information, there is no suspected malfunction with the terumo bct device or allegation of a malfunction.

Manufacturer Narrative

This report is being filed to provide additional information.Additional investigation: based on internal terumo bct medical review, the cause of the patient death was disease state.The device did not cause or contribute to the patient death.The customer declined retraining for this incident.

Manufacturer Narrative

Additional investigation: a terumo bct service representative confirmed that a full diagnosis was made on this machine which did not reveal any deviations.The control and safety stacks were not replaced since no issues were found at the time of service.

Event Description

The patient¿s official release record and/or autopsy report were requested from the hospital¿s medical records department.Information, such as name, dob, and ssn, was stated as necessary to obtain those records.Previous attempts to obtain the patient id were unsuccessful and therefore, the official medical reports could not be obtained.

• 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: 7042998
• MDR Text Key: 92554088
• Report Number: 1722028-2017-00449
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: BY
• 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,Followup
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2018
• Device Catalogue Number: 10220
• Device Lot Number: 05Z3103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2016
• 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: 25