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

Model Number 10310

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation: terumo bct call specialist informed the customer at the time of the call that the plasma they collected at the beginning of the run may possibly be diluted with saline.Adjusted fluid balance calculation: 138.15%.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that 45 minutes into a continuous mononuclear cell (cmnc) collection procedure, they noticed that the saline roller in the inlet line had been left open.Per the customer, the 1l saline bag was about half empty.The operator closed the roller.The patient did not have any symptoms or issues and the customer was able to continue the procedure once the saline roller was closed.No medical intervention was required for this event.Patient information is not available at this time.The 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 in h.6 and h.10.Investigation: patient's tbv: 6993 ml system generated final fluid balance: 2149 ml unintended saline bolus to patient = 243 ml [1000 ml - 297 ml (used to prime the set) + 40 ml (prime diverted back to the saline bag) - 500 ml = 243 ml] final fluid balance = +2392(2149 ml + 243 ml saline) or 134% [(6993 + 2392)/6993 x 100% = 134%] root cause: based on the customer's statements, the root cause was the operator failed to follow the screen prompt to close the inlet saline roller clamp at the end of prime divert.

Event Description

The customer declined to provide patient information.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, and h.10 and updated information in e.3.Investigation: the customer did not provide the disposable lot number.However, the reported adverse event did not relate to activities associated with the manufacture of this lot; therefore, a dhr search is not warranted.All lots must meet acceptance criteria for release.Correction: the terumo bct clinical specialist discussed the importance of following the screen prompts to close the inlet saline roller clamp at the time of the initial call.Investigation is in process.A follow up report will be provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10507960
• MDR Text Key: 206187675
• Report Number: 1722028-2020-00430
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2020

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 Model Number: 10310
• Device Catalogue Number: 10310
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 09/22/2020; 10/09/2020
• Supplement Dates FDA Received: 10/01/2020; 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other