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

Model Number 70700

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

Patient Problems Heart Failure/Congestive Heart Failure (4446); Liver Failure (4492)

Event Date 03/31/2020

Event Type  Injury  

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 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." 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).Patient 5 was diagnosed with sinusoidal obstruction syndrome (sos) on day 109 post-ahsct following a liver biopsy and required repeat liver transplantation on day 170 post-ahsct.There were episodic elevations in liver enzymes (alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase) early post-ahsct, which were likely due to cholangitis as clinical improvement and normalization of liver chemistry occurred with short courses of antibiotics.In patient 5, liver enzymes initially stabilized post-ahsct, but rose abruptly after he developed sos.This report is being filed for patient 5.Further patient information is not provided in the article.The leukapheresis sets are not available for return for evaluation.

• Brand Name: COBE SPECTRA
• Type of Device: 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: 16414311
• MDR Text Key: 309967262
• Report Number: 1722028-2023-00073
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583707009
• UDI-Public: 05020583707009
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: BK020041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 70700
• Device Catalogue Number: 70700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2023
• 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
• Patient Age: 40 YR
• Patient Sex: Male