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

Model Number 10310

Device Problems Self-Activation or Keying (1557); Use of Device Problem (1670)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/19/2019

Event Type  malfunction  

Manufacturer Narrative

Lot number and expiry information are not available at this time.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 with a pediatric patient on a spectra optia device, the system prompted to perform a custom prime.Per the customer, the prompts to perform a custom prime were rejected by the doctor.The system performed only a partial rinseback at the end of the procedure.Per the customer no medical intervention was required and no injury occured.Patient information and outcome are unknown at this time.The 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 in h.10.Investigation: fluid balance correction: the operator declined to perform a custom prime (rinseback defaulted to yes) and according to the dlog, the procedure was completed with rinseback.The ending fluid balance reported by the system was 112%.Rinseback volume was 134ml (it appears that only the first rinseback stage was performed).Relevant info: patients tbv: 1275ml max idl ecv: 297ml rinseback volume: 134ml ending fluid balance: 112% ending fluid balance fb: 165ml 297ml- 134ml = 163ml 163ml+165ml = 328ml (1275 + 328)/1275 x 100 = 125.7% investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.10.Investigtion: the run data file (rdf) was reviewed for this event.Review of the dlog indicates the operator declined custom prime.Since custom prime was not performed, the system performed a partial rinseback.Custom prime is an option, not a requirement, for patients with a low tbv or low hct.This provides a way for the patient to tolerate the volume of the extracorporeal circuit.In this procedure the operator was recommended to perform custom prime.If custom prime is not performed, a partial rinseback should be performed and the system defaults to a partial rinseback.A partial rinseback allows the system to give the patient some of the rbc remaining in the tubing set.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

Investigation: during follow-up with the customer, they reported that there was a definite situation of undeclared and unexpected restrictions on the devise side.Per the customer, the system prompt for custom prime was rejected based on patient¿s condition and the physicians great experience, and when only partial rinseback was possible, the doctor physician performed a manual rinseback.The customer reported that the situation was simulated by the physician later by inputting patient data even without loading a tubing set.The customer reported the following: total amount of fluids machine gave (displayed): 227 ml (ac), 134 ml (rinseback) total fluids removed/collected (displayed): 163 ml investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in investigation :the device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.Final fb: patients tbv: 1275ml fluid balance (from dlog) = 165ml fluid remaining in the set = 297ml (max idl ecv) ¿ 163ml ( partial rinseback vol) = 134ml 165ml + 134ml = 299ml.1275 + 299 /1275 x 100 = final fb 123% the selecting procedural options of the spectra optia apheresis system essentials guide, page 71, the system considers the patient's tbv and fluid balance safety limit when determine the volume of fluid that can be used to perform rinse back.Investigation is in process.A follow up report will be provided.

Event Description

Per the customer, no medical intervention was required for this event.

Manufacturer Narrative

This report is being filed to provide additional information in b.5 and h.6 and corrected information in h.10.Corrected investigation: there were no events noted in the dhr that would have contributed to the event experienced by the customer.Investigatgion is in process.A follow up report will be provided.

Manufacturer Narrative

This report is benig filed to provide additional information in h.6 and h.10.Updated investigation: according to the rdf, the procedure was completed and partial rinseback was performed due to fluid balance constraints.The ending fluid balance reported by the system was 112%.The physician subsequently performed a manual rinseback returning the remaining fluid in the tubing set back to the patient.The patient's final fluid balance was calculated to 299ml which resulted in a worst-case fluid balance of +23%.Correction: the terumo bct provided the customer with information via email clarifying rinseback procedure.The customer understood and acknowledged the receipt of this information.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.Root cause: review of the dlog confirmed that the operator declined custom prime.Since custom prime was not performed, the system performed a partial rinseback due to fluid balance constraints.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: gary dark ; 10810 w collins ave; lakewood, CO 80215 ; 3035425102
• MDR Report Key: 9506972
• MDR Text Key: 187100381
• Report Number: 1722028-2019-00435
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Model Number: 10310
• Device Catalogue Number: 10310
• Device Lot Number: 1908303231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2019
• 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: 00005 YR
• Patient Sex: Female
• Patient Weight: 17 KG