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

Catalog Number 12220

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

Patient Problems Anemia (1706); Cardiac Arrest (1762); Death (1802)

Event Date 08/22/2020

Event Type  Death  

Manufacturer Narrative

Investigation: the customer provided a further report: "a (b)(6)-year-old man with a history of significant coronary artery disease (status post percutaneous coronary intervention), and metastatic prostate cancer was admitted for repeat percutaneous coronary intervention ((b)(6) 2020).On admission, he was found to have significant thrombocytopenia (platelet count of 31 x 1000/ul) thought to be due to thrombotic thrombocytopenic purpura.His troponin levels were slightly elevated above the cut-off value without ekg findings, and attributed to a non-st-elevation myocardial infarction event.He underwent serial plasmapheresis (commencing on (b)(6) 2020) in the hope of reversing the thrombocytopenia.He also developed significant anemia (hemoglobin 6.3 g/dl) during this time, and required transfusion with two units of packed red blood cells.During the fourth plasmapheresis procedure ((b)(6) 2020), he suffered a cardiac arrest and was found to have ventricular tachycardia progressing to pulseless electrical activity.After 20 minutes of resuscitation, no return of spontaneous circulation was achieve.The patient was pronounced deceased at that point.The next of kin declined an autopsy." a terumo bct technician did a full functional checkout of the device at the customer site.Functional check autotest saline run performed.Action taken: completed the power up cycle without any alarms or failures occurring.The following tests were conducted to verify machine functionality: internal and external visual inspections result = passed.Verification of all pressure sensor calibrations result = passed.Safety and control alarm led test result = passed.Cassette plate up/down test result = passed.Rotor occlusion test result = passed.Aims start up/post start up test result = passed.Electrical safety check/test result = passed.Complete autotest result = passed.Saline run result = passed.The optia completed all functional testing without any alarms or failures occurring.Verified machine operations.The run data files were analyzed for this event.This procedure was configured to have an inlet to ac (inlet:ac) ratio of 30 at the start of the run and was not changed throughout the entirety of the procedure, there were no signs of clumping in the run.Furthermore, the maximum ac infusion rate, which determines how quickly ac is delivered back to the patient, was set to 1.2ml/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.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 appeared to be operating as intended.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a therapeutic plasma exchange (tpe) procedure, a patient with coronary artery disease, metastatic prostate cancer anthrombotic thrombocytopenic purpura complained of shortness of breath and chest pain.The patient was noted to have hypotension (blood pressure 80s/40s), decreased oxygen saturation (low 90s/upper 80s), "slow mentation," and "chest discomfort" per the medical record.These signs and symptoms resolved with intravenous fluid bolus.The patient suffered a cardiac arrest, and was found to have ventricular tachycardia progressing to pulseless electrical activity.After 20 minutes of resuscitation, no return of spontaneous circulation was achieve.The patient was pronounced deceased at that point.Per the patient's physician, cause of death was determined to be due to coronary artery disesase.During the tpe, the patient was receiving 0.9% normal saline intravenous fluid and abo-compatible fresh frozen plasma (6 units thawed) as well as oxygen.No reaction report was done and an autopsy was not performed.Per the customer, the dvice was not supected as a factor in the death.The disposable set is not available for return because it was discarded by the customer.This report is being filed due to patient death, though at this time, it is not alleged that the device caused, or contributed to the death.

Manufacturer Narrative

This report is being filed to provide additional information in h6 and h10.Investigation: a disposable history search found no other reports of a similar issue associated with lot 2005193130.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.

Manufacturer Narrative

This report is being filed to provide additional information in a.5a.A.5b h1, h6 and h10.Investigation: per terumo bct's medical review, the device did not cause or contribute to the reported death.Root cause: based on the information from the clinical and investigational findings, the cause of the patient's death was likely due to the pre-existing disease condition.A definitive root cause for the aim alarm could not be determined.Possible causes include but are not limited to dirt or haze on the filler aperture plate and/or on the aim system components and/or the bottom camera strobe.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET,EA
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10554531
• MDR Text Key: 207574726
• Report Number: 1722028-2020-00450
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2022
• Device Catalogue Number: 12220
• Device Lot Number: 2005193130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PREDNISONE (1MG/KG/DAY)RITUXIMAB (100MG IV/WK); PREDNISONE (1MG/KG/DAY)RITUXIMAB (100MG IV/WK)
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Weight: 61