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

Model Number 12320

Device Problems Defective Component (2292); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/10/2019

Event Type  Injury  

Manufacturer Narrative

Investigation: the provided medwatch form did not contain reporter name or facility information, therefor no further details could be obtained for this event and the customer could not be contacted for further details.Terumo bct was included in the initial reporter information.Investigation is in process.A follow-up report will be provided.- [medwatch mw5091508.].

Event Description

Terumo bct received the follow complaint via medwatch form, an autologous cellular therapy (ctp) collection was performed on a pediatric patient with multiple myeloma using a spectra optia device.The ctp collection was performed per protocol without any issues throughout the procedure except for a few occlusion alarms towards the last hour of the procedure which were central venous catheter related.The patient peripheral cd 34 count of 90 and a total of 16.182 liters of whole blood was processed via a triple lumen trifusion central venous catheter.Acda-a ratio used throughout the procedure was 12:1.At the end of the procedure the ctp labeling was verified for accuracy and visual inspection of the ctp was performed and authenticated by two rn's.No visual abnormalities of the ctp were noted prior to distribution to the processing facility.The processing facility personnel who accepted the ctp also confirmed the visual inspection of the ctp showed no abnormalities at the time of distribution at approx 1400, as stated by the processing facility personnel, the md was notified and he visually assessed the ctp.After close inspection of the ctp, the ctp was deemed unusable.The customer reported on the medwatch form that the event report type was "serious injury" and the event outcome was "required intervention".It is unknown what serious injury or intervention was required as that was not provided by the customer.The customer did not provide patient id, weight and outcome on the medwatch, and therefore, this information is not available.The disposable 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: the disposable set was not available for return.The medwatch report lists the procedure date as (b)(6) 2019 but does not include the machine serial number.Therefore, a run data analysis could not be performed.This is an autologous collection on a male patient with diagnosis of multiple myeloma.The customer stated that the collection was performed without any issues throughout the procedure, except for a few access alarms which they attributed to the central venous catheter.The patient¿s peripheral cd34 count was 90 and a total of 16.182 l of whole blood was processed.Ac ratio used throughout the procedure was 12:1.At the end of the procedure, the product was inspected and no abnormalities were found by two nurses.The product was distributed to the processing facility and accepted by personnel.At approximately 1400, the physician was notified and the product was deemed unusable due to clotting.It is unclear what serious injury the patient sustained, or the medical intervention required.It is possible that the patient had to undergo another round of g-csf stimulation in order to collect additional stem cells for transplant.There are known side effects with filgrastim (gcsf).The following side effects are common (occurring in greater than 30%) for patients taking filgrastim: - thrombocytopenia (low platelet counts) - nausea - fever - bone pain.Bone pain may be relieved with over the counter medications which includes pain relievers such as nsaids (ibuprofen) or antihistamines (claritin).Talk with your doctor before taking any over the counter agents.These side effects are less common side effects (occurring in about 10-29%) of patients receiving filgrastim: blood test abnormalities (temporary elevation in lactate dehydrogenase, and alkaline phosphatase).These will return to normal once treatment is discontinued.Tenderness and redness at the site of injection.Petechiae (a small red or purple bump, which is caused by bleeding under the skin) back pain - epistaxis (nosebleeds) - cough - dyspnea (shortness of breath) 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.Investigation: it is unclear what serious injury the patient sustained, or the medical intervention required.It is possible that the patient had to undergo another round of g-csf stimulation in order to collect additional stem cells for transplant.The procedure ran smoothly without any allegation of an adverse event.Based on the investigation, there is no evidence to suggest device malfunction or operator error contributed to the event.Root cause: a definitive root cause for the alleged injury to the patient could not be determined at this time due to a lack of information available.A definitive root cause for clotting in the product could not be determined.Possible causes include, but are not limited to: inadequate anticoagulation of the extracorporeal system for the patient's physiology - failure to manipulate the collected product throughout the procedure - product storage and transportation procedures that were outside of specification.

Manufacturer Narrative

Investigation: the device history record (dhr) was reviewed for this lot.There were no issues identified in the dhr that would have contributed to the event.All quality and sterilization requirements passed.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
• MDR Report Key: 9575090
• MDR Text Key: 174669671
• Report Number: 1722028-2020-00017
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Model Number: 12320
• Device Catalogue Number: 12320
• Device Lot Number: 1907303230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 01/10/2020
• Supplement Dates Manufacturer Received: 01/21/2020; 04/23/2020; 05/20/2020
• Supplement Dates FDA Received: 02/04/2020; 05/07/2020; 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00006 YR