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

Catalog Number 10220

Device Problems Excess Flow or Over-Infusion (1311); Inadequate User Interface (2958)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 03/05/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that after priming the set on spectra optia,they received 'patient maybe hypervolemic' alarm.It is unknown at this time if a medical intervention was required for this event.Patient information and outcome is unavailable at this time.The optia exchange set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Further evaluation of this event has determined that the device did notcauseor contribute to a death or serious injury, nor is there a likely potential for death or seriousinjuryassociated with this event based on additional investigational information.During subsequentfollow up with the customer, it was confirmed that the reported alarm occured beforeconnectingthe patient and starting the procedure and therefore there is no concern of hypovolemia forthisevent.A review of the device history record (dhr) for this unit showed no irregularities duringmanufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.A terumo bct global clinical marketing specialist spoke to the customer regarding this issueandexplained the importance of accurately configuring the secondary plasma device (spd).Root cause: review of the dlogs indicate that multiple configuration changes to the plasmadevice prime volume likely contributed to the reported ¿patient may be hypervolemic¿ alarm.The¿patient may be hypervolemic¿ alarm is generated when the safety system detects the patient¿sfluid balance was changed too quickly.If the operatorgoes back from the start run screen to initiate a device prime during an spd procedure andmultiple prime volume changes are made, as in this case, a large fluid balance/hour can accruepriorto start of the run and generate this alarm.Additionally, this alarm should not be active duringprime as the patient is not connected.As such this issue has been escalated internally foradditional investigation.Once this alarm is generated during prime, the recommended way toclearit is to disconnect and load another kit.A new kit was eventually loaded, and the run was abletoproceed.

Event Description

The customer reported that after priming the set on spectra optia, they received 'patient maybe hypervolemic' alarm.The procedure was discontinued and a new set was loaded, afterpriming the same alarm was received.The procedure was discontinued again, a new set wasloaded and the run was able to proceed.No patient was connected at the time of the events, therefore, no patient information isreasonably known at the time of the event.As the events occured prior to patient connect,there was no impact or consequence to the patient.Weight was included as part of a system limitation.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8464593
• MDR Text Key: 145979890
• Report Number: 1722028-2019-00074
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K172590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

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: 03/01/2020
• Device Catalogue Number: 10220
• Device Lot Number: 1803213230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/05/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 04/18/2019
• Supplement Dates FDA Received: 04/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 89