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

Model Number 12120

Device Problems Excess Flow or Over-Infusion (1311); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: 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 while performing a procedure on spectra optia they had interface issues.Per the customer, during troubleshoot to verify the disposable set installation, it was discovered that saline roller clamp on the inlet line was left open creating an uncontrolled saline passage to the patient.Per the customer, the vital signs of the patient were assessed and found within the expected parameters.A diuretic was given to the patient.The patient information and outcome is not available at this time.The spectra optia collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

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.

Manufacturer Narrative

This report is being filed to provide updated information in investigation: the procedural cautions section of the spectra optia apheresis systemessentials guide states that if the roller clamp on the saline line is left completely open when thepatient is connected, the patent will be quickly infused with a large volume of saline.Tbv*: 3651ml*calculated using nadler's total blood volume formula with the provided height (1.45m), weight(72kg), and gender (f).Ac to the patient: 986 mlsaline bolus: 1000 mlfinal fluid balance = 3651 + 1986 = (5637/3651) * 100 = 153%this final fluid balance represents the worst case scenario assuming no stem cell product wascollected into the collect bag, and all ac went back to the patient.On 08/26/2019, the operator was re-trained on the importance of following the screen promptsto close the inlet saline roller clamp.Investigation is in process, a follow-up report will be provided.

Event Description

Per the customer, after taking the diuretic, the patient's vital signs returned to normal.

Event Description

During follow-up with the customer, it was reported that a saline bolus of 1000ml was used forthis procedure.The customer declined to provide patient age.

Manufacturer Narrative

This report is being filed to provide additional information in investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Updated investigation: tbv*: 3651ml *calculated using nadler's total blood volume formula with the provided height (1.45m), weight (72kg), and gender (f).Ac to the patient: 986 ml saline bolus: 1000 ml intended final fluid balance, without saline bolus = [(3651+986)/3651]*100 = 127% final fluid balance with saline bolus = [(3651+1986)/3651]*100 = 154% the final fluid balance with the saline bolus represents the worst case scenario, assuming no stem cell product was collected into the collect bag, and all ac went back to the patient.This fluid balance is an additional 27% higher than the final fluid balance reported by the device and is more than 20% higher than the intended fluid balance for the collection procedure.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8926156
• MDR Text Key: 155700924
• Report Number: 1722028-2019-00240
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583121201
• UDI-Public: 05020583121201
• Combination Product (y/n): N
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/23/2019

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 Expiration Date: 09/01/2020
• Device Model Number: 12120
• Device Catalogue Number: 12120
• Device Lot Number: 1809213330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/23/2019
• Supplement Dates Manufacturer Received: 08/27/2019; 09/25/2019; 11/20/2019; 01/08/2020
• Supplement Dates FDA Received: 09/17/2019; 10/11/2019; 11/25/2019; 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 72