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

Catalog Number 10310

Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

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

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation:the customer initially reported 'inlet low pressure' alarms and found that the patient had the peripheral ivs in the same arm causing the alarms.After switching the inlet and return lines the 'inlet pressure low' alarms were resolved.Terumo bct performed a calculation from the information provided by the customer,the calculated final fluid balance was 161%.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a continuous mononuclear cell (cmnc) collection procedure they received 'interface was taking too long to establish' alarms.The operator adjusted the patient¿s hematocrit (hct) from 33% to 30%, and then increased to 37% when updated information was received, however, the 'interface alarm' continued.The customer contacted terumo bct support for troubleshooting.The attending nurse stated that the interface was observed to be low and the terumo bct support specialist asked her to lower the hct to 34%and collect port value (cp) to 48% and noticed that the interface came up.The operator was informed to lower the cp to 45% and the collect valve opened.The operator reported that the saline was dripping and confirmed that saline roller clamps on the inlet and return lines were closed.The support specialist suggested to clamp below the roller clamps that resulted in slowing down the saline flow and rinseback was performed.The terumo bct support specialist asked the customer to restart the procedure on the patient with hct at 33%.The interface was observed in the correct position and the customer continued the procedure.The customer reported that the patient received approximately 750 mls of normal saline (ns) from the 1st bag and 800 mls of normal saline (ns) from the 2nd bag.Per customer, the patient is reported in the stable condition.The customer declined to provide the patient (donor) identifier.Patient (donor) age is not available at this time.Terumo bct is awaiting return of the cmnc set for evaluation.

Manufacturer Narrative

This report is being filed to provide additional information.Root cause: based on the clinical findings, it was found that the operator was having problems with the patient's inlet access, and had to switch the inlet and return accesses.It is possible that when the system was paused during the troubleshooting, the operator had to do a slow saline drip in order to keep the inlet and return accesses from clotting.After the operator was able to establish a constant inlet flow, the clamp remained in the partially open position resulting in excess's a line coming into the inlet side.It is also possible that the saline clamp was defective, and it failed to fully occlude the inlet saline line.

Event Description

The customer did not respond to the multiple attempts to gain information on the return of the disposable set.

• 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: 7549115
• MDR Text Key: 109900012
• Report Number: 1722028-2018-00147
• 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
• Report Date: 05/29/2018

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: 09/01/2019
• Device Catalogue Number: 10310
• Device Lot Number: 1709153430
• 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: 05/04/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 06/19/2018
• Supplement Dates FDA Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2017
• 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: 00056 YR
• Patient Weight: 97