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

Catalog Number 10220

Device Problems Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 06/24/2020

Event Type  Death  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that approximately one hour into a red blood cell exchange (rbcx) procedure on a sickle cell patient a leak in the centrifuge occurred.Four hours after the procedure, the patient expired.Per the customer, the patient was very hypotensive before he was connected to the device.The patient received 500ml saline bolus during the procedure, after the blood leak was disconnected.The patient also received benadryl and tylenol.Terumo bct is awaiting the autopsy results.The customer does not suspect the device caused the patient death.This report is being filed due to patient death, though at this time, there is no allegation that the device caused or contributed to the patient 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: the customer summarized the autopsy results.The autopsy results confirmed there was no single contributor to the patient's sudden death.The cause of death was determined by the pathologist as multifactorial.Per the customer, the death was not suspected to be related to a device malfunction as the patient was very hypotensive prior to being connected to the device.Patient's final fluid balance was calculated to be 350ml which resulted in a worst-case fluid balance of +6.0%.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The customer submitted one photograph to support the investigation.The photograph confirmed the upper bearing had not been loaded optimally into the upper bearing holder.The upper bearing was inserted into the upper bearing holder at the wide/broad part of the lower upper bearing, causing in the braided mesh becoming disconnected from the upper bearing subsequently resulting in a leak at the 4-luemn adjacent to the lower bearing.Furthermore, the upper bearing remained attached to the upper loop sleeve (the locating ears were intact) and the lower portion of the upper bearing was noted to be worn.Blood was noted to be present on the braided mesh, the filler and the interior of the centrifuge.The run data file (rdf) was analyzed for this event.The signals in the rdf indicate that the spectra optia system operated as intended.There were no unusual alarms and no operational issues that indicate the machine is unsafe.The aim images were clean and clear and the lighting was in the appropriate range.Run summary: actual fluid balance: -7 ml (100%) procedure time: 57 min saline to patient: 45 ml ac to patient: 140 ml rinseback was not completed estimated patient hct: 32% fraction of cells remaining: fcr: 0.62 (target fcr was 0.30) tbv processed 2803ml volume in remove bag: 1685ml replacement volume: 1447ml service was performed on this device.Visual inspection found dried blood on the centrifuge basin on the inside of the front door inside the centrifuge gear shroud and on the gear train.Cleaning of these components was completed.Additionally, no damage and all grounding was secured and resistance was normal.A pressure check on all pressure transducers confirmed all were 100% functional and within manufacturer specifications.A leakage current test and an autotest were completed.All tests passed.The 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 b.5, 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.Investigation is in process.A follow up report will be provided.

Event Description

Per the customer, benadryl and tylenol were prescribed to the patient and it is unknown when the medication was administered.

Manufacturer Narrative

This report is beinf filed to provide additional information in h.6 and h.10 investigation: per internal medical review and analysis, the device did not cause or contribute to this incident.Root cause : based on the customer's statements, supported by the clinical findings, rdf analysis, the service performed on the device, the cause of the patient's death was likely due to the patient's medical condition.The centrifuge leak that resulted in the premature end to the procedure was due to the upper bearing not being loaded into the upper bearing holder optimally.Correction: the customer declined the offer of retraining, since this was a one time issue and the group of operators are very experienced on how to load and manage procedures.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET,EA
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10391450
• MDR Text Key: 202409314
• Report Number: 1722028-2020-00373
• 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: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2022
• Device Catalogue Number: 10220
• Device Lot Number: 2004083130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00033 YR
• Patient Weight: 78