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

Model Number 12320

Device Problems Disconnection (1171); Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 04/29/2020

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry are not available at this time.Investigation: per the customer, it is unclear why the luer lock attachment became loose, but indicated they do not believe it was related to the optia.Per the customer, the patient received before delivery only ringer's lactate solution and oxygen application 2-4 l/min investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that they had a serious event in which an older female patient with diffuse large b cell lymphoma had collected stem cells using the continuous mononuclear cell (cmnc) procedure on optia successfully for three hours.The perfusor had run out of calcium and had alarmed, the operator that went to the patient noticed approximately 200 to 300 ml of blood from the patient that was on the floor.The operator had noticed that the connection between the sheldon catheter and the tbct inlet line had become disconnected.Furthermore the operator noticed a centrifuge pressure alarm.The patient noted pressure on the chest, breathing issues that then required oxygen, and cardiac decompensation.The procedure was discontinued and the patient was stabilized (with monitoring of vital functions) and transferred to the intensive care unit.The patient remained on the intensive care unit overnight and was released the next day.A sufficient dose of stem cells was obtained in the three hours thus an additional apheresis procedure was not required.Per the customer, the patient status in the same as prior to the incidient, corresponding to the pre-exisitng illness.Patient id is not available at this time.The disposable set is not available for return because it was discarded by the customer.

Event Description

Due to eu personal data protection laws, the patient information is not available from the customer.

Manufacturer Narrative

This report is being filed to provide additional information in b.5 and h.10.Investigation: the lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Vasovagal incidents occur around 0.5% of procedures.The reactions generally manifest as pallor and diaphoresis.In a full blown attack, the reaction progresses from pallor and sweating to pulse slowing and blood pressure decreasing.More severe vasovagal reactions may include nausea, vomiting, and/or convulsions.Investigation is in process.A follow up report wil be provided.

Manufacturer Narrative

This report is being filed to provide additional information in b.5 and h.10.The patient's total blood volume is estimated to be 4264 ml.The hematocrit was initially entered as 33% and then updated to 28% 12 minutes into the procedure.No rinseback was performed.Estimated total loss of red cells (after leak and no rinseback) = (300 ml + 297 ml) x.28 = 167.2 ml.Air was likely drawn into the system through the inlet port, and created an air block in the centrifuge lines that triggered the centrifuge pressure high alarms.Based on the information from the clinical and investigational findings, there is no evidence to suggest the device caused or contributed to the patient's reaction.Investigation is in process.A follow up report will be provided.

Event Description

The customer declined to provide further procedural details as they reported that they did not believe the issue was related to the tbct device.

Manufacturer Narrative

This report is being filed to provide additional information in b.6 and h.10 and corrected information in h.10.Investigation: the run data file was analyzed for this event.Review of the run data file (rdf) and aim images suggest that air was introduced through the inlet line into the disposable kit which led to the centrifuge pressure alarm and the operator ending the procedure earlier than expected.Analysis showed that there were no access alarms generated during the run and that the procedure was uneventful until the ¿centrifuge pressure exceeded limit¿ alarm was generated at 203 minutes into the run.This alarm occurs if the centrifuge pressure is detected as greater than 1350mmhg.This alarm stops the centrifuge to prevent damage and/or potential leaks in the centrifuge.This alarm most commonly occurs if air enters the centrifuge, which can happen if the channel is not loaded correctly or, more likely in this case, if the inlet access is not secure or disconnects during the procedure.Based on the signals in the rdf and the complaint description, it is likely that the inlet luer became disconnected from the catheter and that air was pulled into the inlet line, entered the centrifuge and caused the centrifuge pressure alarm generated.The operator did not resume the procedure after the pressure alarm occurred and rinseback was not performed.It was noted that the operator both decreased and increased the inlet:ac ratio value multiple times during the procedure.Review of the aim images did not show any signs of clumping however it is possible it was present.The estimated loss of red cells due to a leak of up to 300 ml is 84 ml (0.28*300ml) and the estimated rbc volume in set at procedure termination is 100 ml giving a total loss of up to 184 ml rbc.Corrected investigation: according to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Respiratory distress occurs in around 0.3% of procedures.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

Investigation: a lot history search confirmed there were no other reports of a similar issue for this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Updated blood loss estimation: the estimated loss of red cells due to a leak of up to 300 ml is 84 ml (0.28*300ml) and the estimated rbc volume in set at procedure termination is 100 ml giving a total loss of up to 184 ml rbc.Root cause: a definitive root cause for the patient's reaction could not be determined.Possible causes for the alleged respiratory distress include but are not limited to patient disease state, patient anxiety about the blood leak, or acute blood loss as a result of the leak.A definitive root cause for the access luer leak could not be determined.Possible causes include but are not limited to: - a defective competitor component part - a loose connection - a damaged luer (caused by molding process or excess solvent application during manufacturing) - cross threading of the two luer ends.Corrected investigation: during the investigation it was determined that the statement "according to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Respiratory distress occurs in around 0.3% of procedures." is not relevant to this event.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10114668
• MDR Text Key: 200981912
• Report Number: 1722028-2020-00271
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Model Number: 12320
• Device Catalogue Number: 12320
• Device Lot Number: 1910223230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00058 YR
• Patient Weight: 75