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

Catalog Number 10220

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Patient Involvement (2645)

Event Date 03/04/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information (b)(6).Investigation: the optia essentials guide informs the operator of the following: when preparing to perform a procedure, ensure that the lines are connected to the correct fluids, and that fluid is flowing into the drip chambers: ac line (orange) to the anticoagulant container saline line (green) to the normal saline (0.9%) container.Ac spike is orange and matches the tint of the ac tubing to differentiate it from other spikes on the disposable set.Saline spike is green and matches the tint of the saline tubing to differentiate it from other spikes on the disposable set.Additionally, the software screen prompts are also color coded (orange for ac and green for saline) to differentiate the two and direct the operator to match the color coded spikes.The customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Investigation is in-process.A follow-up report will be provided.

Event Description

The customer reported that during prime on spectra optia they inadvertently spiked anticoagulant on wrong spike.The customer contacted terumo bct support specialist for troubleshooting.Per the operator, during prime she noticed that the anticoagulant was spiked on the wrong line and wanted to know if the lines can be switched to continue the run.The customer also stated that the lines were not primed with the appropriate fluid.The support specialist instructed the operator to unload the disposable set and to discontinue the procedure.The customer did not respond to multiple attempts to obtain information for the investigation such as patient information, procedural details and lot information.Since the error was found during prime, the patient was not connected to device at the time.No adverse events were reported and no medical intervention was necessary as a result of the error.The spectra optia exchange set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Correction: at the time of the reported incident, the terumo bct clinical specialist explainedwhy the procedure could not be continued by switching the lines.The operator verbalizedunderstanding.Root cause: the root cause of the anticoagulant being spiked on the wrong line was a failure ofthe operator to follow screen prompts to ensure spiking the correct solution by matching theorange color coded spike with the orange tubing.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8464244
• MDR Text Key: 146401457
• Report Number: 1722028-2019-00069
• 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: 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 Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 03/29/2019
• Supplement Dates FDA Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other