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 Problem Pulmonary Embolism (1498)

Event Date 03/17/2021

Event Type  Injury  

Manufacturer Narrative

Investigation: before the code, the customer reported that they started having difficulty getting o2 sats, the patient had agonal respirations.Per the customer, "the patient was sick and [the code] was respiratory in nature." the autopsy results confirmed the cause of death was reported as a pulmonary embolism due to the patient waiting 5 days in sickle crisis at home before going to hospital.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Per the customer the device passed its check without issue.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that the patient coded during a red blood cell exchange (rbcx) procedure on a spectra optia device.The code started during the first unit of blood, about 20 minutes into the procedure.During the procedure, the patient was receiving benadryl 25 mg iv, solu cortef 100 mg ivp, calcium gluconate 2 gm 100 cc ns was started.The patient death was due to disease state and the customer confirmed that the device did not cause or contributed to the death.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.6 and h.10.Investigation: a disposable lot query was performed for lot 2012173130 and confirmed there were no occurrences of a similar issue reported against this lot worldwide to date.The run data file (rdf) was analyzed for this event.The signals in the rdf indicate that the spectra optia system operated as intended.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h6 and h10.Investigation: according to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Some of the most common reactions include fever, urticaria, hypocalcemic symptoms, pruritus, dyspnea, tachycardia, and mild hypotension.A service was completed on device 1p01229.A full auto test aim startup and post startup test including a saline run was performed.All tests passed (after replacement of the display housing) and device 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 h.6 and h.10.Corrected information is provided in h.10.Investigation: the customer did not respond to request for timing of medication administration.Root cause: based on the provided information from the customer and the clinical investigation findings, the optia device performed as intended; there were no alleged device failures, malfunctions, mislabelling, improper or inadequate design or manufacturing errors, nor was there any reported user errors that contributed to or caused this adverse event.Per the customer, the patient¿s cause of death was related to her being in sickle cell crisis for five days at home prior to seeking medical intervention.The specific root causes for administering medications to the patient were unknown since the customer did not allege any adverse reactions related to the device or the procedure.It is possible that they were given prophylactically or for the patient's underlying disease.Corrected investigation: the statement "according to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of (b)(4).Some of the most common reactions include fever, urticaria, hypocalcemic symptoms, pruritus, dyspnea, tachycardia, and mild hypotension." provided in follow-up #2 is no longer applicable to this investigation.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11664942
• MDR Text Key: 245382103
• Report Number: 1722028-2021-00154
• 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): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/14/2021

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: 12/01/2022
• Device Catalogue Number: 12220
• Device Lot Number: 2012173130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/24/2021
• Initial Date FDA Received: 04/14/2021
• Supplement Dates Manufacturer Received: 04/19/2021; 08/23/2021; 09/22/2021
• Supplement Dates FDA Received: 05/07/2021; 08/26/2021; 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00044 YR
• Patient Weight: 62