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

Catalog Number 10310

Device Problems Improper or Incorrect Procedure or Method (2017); Obstruction of Flow (2423); Device Displays Incorrect Message (2591)

Patient Problems Hypervolemia (2664); No Known Impact Or Consequence To Patient (2692)

Event Date 01/09/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer, the spectra optia system displayed the predicted fluid balance at 129%, however, at the end of the procedure, the patient's fluid balance was calculated as 143%.Investigation is in-process.A follow-up report will be provided.

Event Description

The customer reported that while performing rinseback for a spectra optia collection procedure, they received an 'inlet saline line' alarm due to an obstruction.The customer contacted terumo bct support specialist for troubleshooting.While the support specialist instructed the operator to open the inlet saline roller clamp, she discovered that the saline bag was empty.A new saline bag was setup and rinseback was successfully completed.The customer stated that the patient is doing well and was in stable condition during the procedure.The customer declined to provide patient identifier and age.The spectra optia 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 and corrected information.Investigation: the disposable set was not available for return.The run data file (rdf) was analyzed for this event.During analysis it was determined that some of the alarms occurred before the set was primed.Terumo bct technical support examined the rdf and believe that the cause was due to the rotors being loaded incorrectly with the black dot in the wrong location.Tech support stated that the alarms did not contribute to the reported condition for this event.Predicted fb was 129% and patient ended with 143% with the saline that was infused.Customer called for troubleshooting and the problem was identified and corrected by the customer, therefore the customer was aware of the error; no additional retraining is necessary.Root cause: based off the clinical findings and rdf analysis, root cause for the hypervolemia was determined to be the result of the operator leaving the return saline roller clamp open after saline divert.This resulted in a saline bolus going back to the patient.Per rdf analysis, in order to initiate rinseback, the system prompts the operator to open the inlet saline roller clamp.In this case the system did not detect a change in pressure because the inlet saline roller clamp remained closed.The system generated a "inlet saline line obstructed" alarm to alert the operator to open the inlet saline roller clamp.The operator opened the roller clamp and completed rinseback.

Event Description

Full patient identifier (id): (b)(4).

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.

Manufacturer Narrative

This report is being filed to correct information.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
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7239319
• MDR Text Key: 99081672
• Report Number: 1722028-2018-00030
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/02/2018

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: 11/01/2019
• Device Catalogue Number: 10310
• Device Lot Number: 1711023230
• 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: 01/09/2018
• Initial Date FDA Received: 02/02/2018
• Supplement Dates Manufacturer Received: 03/22/2018; 08/22/2018; 11/29/2018
• Supplement Dates FDA Received: 03/23/2018; 09/14/2018; 12/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2017
• 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: 00052 YR
• Patient Weight: 127