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

Model Number	70700
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Liver Failure (4492)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number and expiry are not available at this time.Article citation: chruscinski, a., et.Al.2022.Autologous hematopoietic stem cell transplantation for liver transplant recipients with recurrent primary sclerosing cholangitis: a pilot study.Transplantation.106:3, 562¿574.Doi: 10.1097/tp.0000000000003829 investigation is in process.A follow up report will be provided.
Event or Problem Description
The journal article, 'autologous hematopoietic stem cell transplantation for liver transplant recipients with recurrent primary sclerosing cholangitis: a pilot study' describes a study whether autologous hematopoietic stem cell transplantation (ahsct) could be used to stop progression of recurrent primary sclerosing cholangitis (psc) and promote operational tolerance after liver transplantation.Five patients with clinical, biochemical, radiologic, and histologic evidence of recurrent psc underwent ahsct.Ahsc grafts were collected with a single leukapheresis procedure in all 5 patients."in this pilot study of 5 patients who underwent ahsct for recurrent psc following liver transplantation, 2 are alive and have been off immunosuppressive drugs without evidence of progression of psc or allograft rejection for >3 y, consistent with operational tolerance to self-antigens and alloantigens.However, the myeloablative conditioning regimen (ctx, busulfan, and antithymocyte globulin) had significant toxicity in all of the patients and led to death or the need for repeat liver transplantation in 3 of the 5 patients." patient 2 was completely weaned off all immunosuppression but died at day 212 post-ahsct from pericardial constriction and right heart failure.Complications related to the conditioning regimen were universal and moderate to severe.Three of the 5 patients required admission to an intensive care unit and these 3 patients required a short course of renal replacement therapy (hemodialysis).In patient 2, aspartate aminotransferase and alanine aminotransferase normalized at 6 mo post-ahsct; however, there was an abrupt rise in liver enzymes from liver congestion when worsening right heart failure developed secondary to pericardial constriction.This patient died shortly thereafter, but autopsy showed no evidence of rejection or recurrent psc.This report is being filed for patient 2.Further patient information is not provided in the article.The leukapheresis sets are not available for return for evaluation.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.It was confirmed that upon review the adverse events or deaths were not directly related to the device.Article citation: chruscinski, a., et.Al.2022.Autologous hematopoietic stem cell transplantation for liver transplant recipients with recurrent primary sclerosing cholangitis: a pilot study.Transplantation.106:3, 562¿574.Doi: 10.1097/tp.0000000000003829.No further reporting will be provided as this does not represent a reportable event.
Event or Problem Description
The journal article, 'autologous hematopoietic stem cell transplantation for liver transplant recipients with recurrent primary sclerosing cholangitis: a pilot study' describes a study whether autologous hematopoietic stem cell transplantation (ahsct) could be used to stop progression of recurrent primary sclerosing cholangitis (psc) and promote operational tolerance after liver transplantation.Five patients with clinical, biochemical, radiologic, and histologic evidence of recurrent psc underwent ahsct.Ahsc grafts were collected with a single leukapheresis procedure in all 5 patients."in this pilot study of 5 patients who underwent ahsct for recurrent psc following liver transplantation, 2 are alive and have been off immunosuppressive drugs without evidence of progression of psc or allograft rejection for 3 y, consistent with operational tolerance to self-antigens and alloantigens.However, the myeloablative conditioning regimen (ctx, busulfan, and antithymocyte globulin) had significant toxicity in all of the patients and led to death or the need for repeat liver transplantation in 3 of the 5 patients." patient 2 was completely weaned off all immunosuppression but died at day 212 post-ahsct from pericardial constriction and right heart failure.Complications related to the conditioning regimen were universal and moderate to severe.Three of the 5 patients required admission to an intensive care unit and these 3 patients required a short course of renal replacement therapy (hemodialysis).In patient 2, aspartate aminotransferase and alanine aminotransferase normalized at 6 mo post-ahsct; however, there was an abrupt rise in liver enzymes from liver congestion when worsening right heart failure developed secondary to pericardial constriction.This patient died shortly thereafter, but autopsy showed no evidence of rejection or recurrent psc.This report is being filed for patient 2.Further patient information is not provided in the article.The leukapheresis sets are not available for return for evaluation.

• Brand Name: COBE SPECTRA
• Common Device Name: COBE SPECTRA RBCX 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: 16414131
• Report Number: 1722028-2023-00070
• Device Sequence Number: 19655725
• Product Code: LKN
• UDI-Device Identifier: 05020583707009
• UDI-Public: 05020583707009
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: BK020041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 70700
• Device Catalogue Number: 70700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2023
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female