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

Catalog Number 10310

Device Problems Backflow (1064); Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)

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

Event Date 10/03/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the medical director¿s order, a hematocrit testing was performed with the normal saline (ns) bag with whole blood.The operator transferred the ns bag with whole blood into a 200 ml bag and the weight was tared.The end volume of the bag was calculated at 2313 ml with a hematocrit (hct) of 20%.The rbcs in the ns bag was also calculated at 463 ml.Per protocol at the customer¿s site, the patient was infused with 50 ml of 5gm calcium gluconatevia iv prior to the start of the cmnc collection procedure.The run data file (rdf) was analyzed for this event.The signals in the rdf indicated that the spectra optia system operated as intended.Signals in the rdf confirmed that at 1 minute, once prime divert was completed, the operator did press the continue button from the "prime saline has been diverted.Close return saline line." prompt to indicate that they had confirmed that the return saline roller clamp had been closed.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a patient was undergoing a continuous mononuclear cell (cmnc)collection procedure.After collecting approximately 14 liters, the operator noticed that the red blood cells (rbcs) were diverting back into the normal saline (ns) bag.The customer stated that approximately 300 ml of packed rbcs diverted back into the normal saline bag.While troubleshooting, they discovered that the saline roller clamp on the return line was left partially open.Per the medical director¿s order, the procedure was continued.The operator performed a partial rinse back for 170 ml and the procedure was successfully completed with manual rinseback.No medical intervention was required for this event.The patient was discharged after the procedure and is reported in stable condition.The customer declined to provide the patient identifier.The cmnc collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: based on the investigation, the root cause was determined and acknowledged by the customer to be the result of an operator error in clamping resulting in blood loss due to the return line pinch clamp being closed and fluids routing to the saline bag through the partially open saline roller clamp.

Manufacturer Narrative

Additional investigation: a calculation for the estimated patient fluid balance was performed by terumo bct using the patient and procedure information from the rdf analysis and information and photographs provided by the customer.The patient's starting tbv was 6300ml, which results in a final tbv of at least 96.6% of the starting total blood volume (tbv).

Manufacturer Narrative

Updated root cause: based on the clinical/technical findings and investigation, the root cause was determined and acknowledged by the customer to be the result of an operator error in clamping resulting in blood loss due to the return line pinch clamp being closed and fluids routing to the saline bag through the partially open saline roller clamp.

Manufacturer Narrative

This report is being filed to provide additional information.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6976983
• MDR Text Key: 91100871
• Report Number: 1722028-2017-00414
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/25/2017

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: 07/01/2019
• Device Catalogue Number: 10310
• Device Lot Number: 1707243230
• Other Device ID Number: 05020583103108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/03/2017
• Initial Date FDA Received: 10/25/2017
• Supplement Dates Manufacturer Received: 03/16/2018; 05/17/2018; 07/24/2018; 08/14/2018
• Supplement Dates FDA Received: 03/30/2018; 05/18/2018; 07/25/2018; 08/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2017
• 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 Age: 00064 YR
• Patient Weight: 114