MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA APHERESIS SYSTEM

Model Number 61000

Device Problems Computer Software Problem (1112); Device Displays Incorrect Message (2591)

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

Event Date 04/05/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: the device serial number history report indicates no further related issues have been reported for this device.The run data file (rdf) was analyzed for this event.The ¿patient hematocrit data was invalid¿ alarm will occur if the optia safety system has detected that the patient¿s hematocrit is out of range.The actions leading to the generation of this alarm is not confirming the entry of patient data once the screen has been accessed, before optia completes prime of the disposable set.This alarm is a procedure ending alarm and will not allow the operator to continue the run.This issue occurs in v12.0 software only.This alarm is generated when the operator opens the patient data screen during the priming of the disposable tubing set and does not confirm the patient data until after the prime sequence completes.If the patient data is confirmed after prime completes, the alarm will be generated when the operator next touches the patient data tab which could be during the procedure.If this alarm is triggered during the procedure, rinseback is not allowed.This is a known software issue with that occurs in v12.0 that has been addressed in a future software release.In order to avoid this alarm, the operator needs to either enter the patient data and press confirm before the prime sequence is complete or the operator can wait to enter and complete the patient data screen after the priming sequence has completed.The reported alarm was confirmed in the rdf.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that five minutes into a therapeutic plasma exchange (tpe) procedure for suspected thrombotic thrombocytopenic purpura (ttp), the spectra optia device alarmed 'patient hematocrit data not valid'.The only option for the customer was to disconnect (no rinseback available).Per the customer, the patient's hematocrit was only 15% at the commencement of the procedure.During the initial call from the customer, the operator was specifically asked about the timing of the entry of the patient data ¿ they stated the operator waited until the screen appeared and only entered when prompted to do so.Patient identifier, age, and outcome are not available at this time.Patient¿s weight was obtained from the run data file (rdf).

Manufacturer Narrative

This report is being filed to provide additional information in a.4 and b.5.Investigation is in process.A follow-up report will be provided.

Event Description

Patient gender was obtained from the run data file (rdf).

Manufacturer Narrative

Investigation: the device serial number history report indicates no further related issues have been reported for this device.Additional complaints were identified (8 complaints total) with similar descriptions and from the investigation on those, it is found that this issue is related to optia v12.0.X software on the exchange protocols only and is a result of the timing when the patient data is entered and confirmed.One year of service history was reviewed for this device.Five records were found with similar issues related to the reported condition identified.After the most recent incident prior to this event, on (b)(6) 2020, the customer was informed of the following: this is a known software issue that occurs in v12.0 that has been addressed in a future software release.In order to avoid this alarm, the operator needs to enter the patient data and press confirm before the prime sequence is complete or the operator can wait to enter the patient data until the priming sequence has completed.Per internal risk documentation, the health hazard risk is low for tpe procedure that does not achieve targeted therapy end point leading to ineffective or delayed therapy.The health hazard risk for hypovolemia is none/negligible, and for over depletion of red blood cells is low, therefore, this event does not present the potential for serious injury.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

Root cause: the ¿patient hematocrit data was invalid¿ alarm will occur if the optia safety system has detected that the patient¿s hematocrit is out of range.This issue only occurs in tpe, spd, and rbx protocols performed using optia v12.0.X software when patient data entered during priming is not confirmed until after completion of the priming sequence.If the hematocrit is not reentered on a secondary patient data entry screen, the software interprets a value of zero for the hematocrit and allows that value to be passed into the system to set up run targets and run parameters.The failure condition subsequently occurs because a zero hematocrit is then used in these calculations.

Event Description

No adverse reactions by the patient were reported and no medical intervention was required for this specific incident.

Manufacturer Narrative

This report is being filed to provide additional information in h10.Corrective action: an internal capa has been opened to address optia v12.0.X software related to timing of when patient data is entered and confirmed.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10025316
• MDR Text Key: 196390847
• Report Number: 1722028-2020-00202
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583610002
• UDI-Public: 05020583610002
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 61000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 92