MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA; COBE SPECTRA TPE SET

Catalog Number 70500

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

Patient Problem Inflammation (1932)

Event Date 03/01/2022

Event Type  Injury  

Manufacturer Narrative

Investigation: there is no evidence to suggest a malfunction of the disposable kit or the cobe spectra device caused or contributed to the reported adverse reactions or the patient death.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Adverse effects related to vascular access are a frequent concern.Hematoma, venous sclerosis and thrombosis can complicate percutaneous needle puncture.Hemorrhage or pneumothorax or both may complicate cvc insertion, while thrombosis and infection are the most frequently observed complications of prolonged central venous access.Dhr details: since this is a retrospective cohort study which was designed primarily to evaluate the role played by therapeutic plasmapheresis using cobe spectra on 28-day in-hospital mortality among patients with severe covid-19 infections and cytokine release syndrome (crs) between (b)(6) 2021, the lot numbers were not provided; therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Conclusion: for this particular group of matched patients with covid-19-induced crs, tpe+sc was linked with relatively better overall survival, early extubation, and earlier discharge compared to sc alone.As these results were not statistically significant, multicentered randomized control trials are needed to further elaborate the role of therapeutic plasmapheresis in covid-19 induced crs.Based on terumo (b)(4) internal medical review conclusion, the cobe spectra device performed as intended, there were no suggested device failures, malfunctions, mislabeling, improper or inadequate design or manufacturing errors, nor was there any reported user errors that contributed to or caused these adverse events.Root cause: a root cause assessment was performed for this complaint.Adverse effects related to vascular access are a frequent concern.Hematoma, venous sclerosis and thrombosis can complicate percutaneous needle puncture.Hemorrhage or pneumothorax or both may complicate cvc insertion, while thrombosis and infection are the most frequently observed complications of prolonged central venous access.Journal article: jamil, et al.: role of therapeutic plasmapheresis in sars-cov-2 induced cytokine release syndrome: a retrospective cohort study on covid-19 patients.International journal of general medicine 2022:15 4907¿4916.

Event Description

The article, 'role of therapeutic plasmapheresis in sars-cov-2 induced cytokine release syndrome: a retrospective cohort study on covid-19 patients', describes a retrospective cohort study which was designed primarily to evaluate the role played by therapeutic plasmapheresis using cobe spectra on 28-day in-hospital mortality among patients with severe covid-19 infections and cytokine release syndrome (crs) between (b)(6) 2021.The effect of plasmapheresis on inflammatory markers, the need for mechanical ventilation, the rate of extubation and survival duration were studied as secondary outcomes.No major complications were observed after therapeutic plasmapheresis.Only 2 patients developed a femoral artery puncture that was managed at the bedside by applying pressure and 1 patient developed thrombophlebitis of the femoral vein in whom the subclavian vein was used for plasmapheresis afterwards.The author did not specify if there was any medical intervention for the patient who developed thrombophlebitis.This is a retrospective cohort study which was designed primarily to evaluate the role played by therapeutic plasmapheresis using cobe spectra on 28-day in-hospital mortality among patients with severe covid-19 infections and cytokine release syndrome (crs) between (b)(6) 2021.A request for specific donor information is not feasible.The device is not available for return for evaluation.

• Brand Name: COBE SPECTRA
• Type of Device: COBE SPECTRA TPE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 14803190
• MDR Text Key: 295107973
• Report Number: 1722028-2022-00205
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: PK
• PMA/PMN Number: BK080035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 70500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention