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

Catalog Number 12220

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hypovolemic Shock (1917)

Event Date 12/07/2020

Event Type  Death  

Manufacturer Narrative

Lot number and expiry are not available at this time.Investigation is in process.A follow up report will be provided at this time.

Event Description

During a meeting with the customer, it was discussed that a patient had expired during a therapeutic plasma exchange (tpe) procedure.The doctors said that the autopsy is ongoing and that they are awaiting conclusions of the autopsy.No further information is available at this time.Patient information is not available at this time.This report is being filed due to a patient death, though there is no allegation that the device caused or contributed to the patient death.The device is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: according to the customer, the autopsy showed hemorrhagic shock probably related to the patient's severe thrombocytopenia.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 patient's vital signs prior to the tpe procedure were normal (stable hemodynamics, normal oxygen saturation in air).The cause of death was determined based on the autopsy during a multidisciplinary meeting with nephrologists, hematologists and pathologists and was due to massive hemoperitoneum, compatible with death from hypovolemic shock (hemmorrhagic shock).No signs of air or blood embolism.The customer did not suspect device malfunction caused or contributed to the patient's death, concluding that the patient expired due to the patient's disease progression.Lab and clinical data were requested but not shared.

Manufacturer Narrative

This report is being filed to provide additional information in d.4, h.4, h.6, and h.10.Investigation: the run data file (rdf) was analyzed for this event.This procedure was configured to have an inlet to ac (inlet:ac) ratio of 11 at the start of the run and was changed to 12 later on in the procedure.Furthermore, the maximum ac infusion rate, which determines how quickly ac is delivered back to the patient, was set to 0.9ml/min/ltbv.This infusion rate is within the soft safety limit of 1.2ml/min/ltbv.Additionally, signals from the dlog showed no unusual alarms or abnormal procedure behavior.Given this information, the device was found to be operating as intended, and within the generally tolerated limits for a majority of patients.There was no system or device malfunction identified that would indicate an issue with the optia system or that the system contributed to the injury/death.The optia system has several protections against air being returned to the donor including a return line air detector and the ability for air to be detected at the lower level sensor to protect from the return of air being returned to the patient.Both of these appeared to be operating as intended and there was no evidence of air detected past the last point of detection.The optia system appeared to be operating as intended.Service was performed on device 1p02574 on (b)(6) 2021.Upon full inspection the device passed all tests and was verified to be operating per manufacturer specifications.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in b.5.Investigation is in process.A follow up report will be provided.

Event Description

Pursuant to eu personal data protection laws, the patient identifier is not available from the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: the disposable lot query was performed for lot 2007203130 and no similar reported occurrences were received against this lot to date.Per internal medical review and analysis, the device did not cause or contribute to this incident.Root cause: based on the physician's statements, supported by the clinical findings, rdf analysis, the service performed on the device, the cause of the patient's death was the patient's medical condition.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11077990
• MDR Text Key: 223798307
• Report Number: 1722028-2020-00576
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/28/2020

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: 07/01/2022
• Device Catalogue Number: 12220
• Device Lot Number: 2007203130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 01/11/2021; 01/27/2021; 03/04/2021; 03/11/2021
• Supplement Dates FDA Received: 01/19/2021; 02/10/2021; 03/04/2021; 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00051 YR
• Patient Weight: 115