MAUDE Adverse Event Report: FENWAL INTERNATIONAL INC. AMICUS SEPARATOR SYSTEM; AMICUS APHERESIS KIT

Model Number N/A

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

Patient Problem Sepsis (2067)

Event Date 10/24/2023

Event Type  Injury  

Event Description

On 11/6/2023, fresenius kabi was notified of a potential septic transfusion reaction.Recipient information: (b)(6) hospital reported that a recipient had a transfusion transmitted bacterial infection (ttbi) reaction after getting a platelet transfusion.The product was collected on (b)(6) 2023 and the transfusion occurred on (b)(6) 2023.Recipient is a 73-year-old male with a history of multiple myeloma and pancytopenia.The recipient was transfused with a pathogen-reduced apheresis platelets unit at (b)(6)hospital.Product information (as provided by american red cross (arc)): the product was collected on amicus as a double platelet product collection with intersol.The final storage container was from a cerus kit.The co-product platelet product was transfused, and the recipient did not have any reaction.Background: complaint information: (b)(4): arc#: dcsc-c-012-tr-sep06911.Location: (b)(6) hospital.Platelet collection date: on (b)(6) 2023.Platelet transfusion date: on (b)(6) 2023.Pas treated: yes.Intercept treated: yes.Bacteria detected: bacillus cereus: found in the recipient's post-transfusion blood cultures and residual cerus platelet bag.Co-product(s): the second platelet unit from the collection was transfused at university of north carolina hospital and there was no reaction.The plasma products were quarantined by arc.Amicus product information: product description: amicus double needle advanced kit.Amicus code: 4r2352.Amicus lot: fa23g24065.Final manufacturing: haina, dr.Acda solution lot: fm23g15014 and fm23g20030.Naci solution lot: fm23g18042.Solution manufacturing: maricao, pr.Intersol (pas) product information: product description: intersol solution platelet additive solution 3.Lntersol code: 6b7880.Intersol lot: fm23g19032.Final assembly: maricao, pr.Cerus corporations intercept platelet storage container product information: product description: intercept blood system for platelets.Lntercept code/model: int2230b.Lntercept lot: ce23e26l71.Registered manufacturer: cerus corporation, 1220 concord, ave, concord ca, 94520, usa.Investigation: code 4r2352, lot: fa23g24065 used the following solution lots: acda solution lot: fm23g15014 and fm23g20030.Nacl solution lot: fm23g18042.A batch traceability (finished good (fg) lot) was performed to trace an amicus fg that used acda solution lots: fm23g15014 or fm23g20030 or nacl solution lot: fm23g18042.Subsequently, reported complaints on the traced fg lots as of 11/30/2023 were reviewed.Based on complaint records, there are no additional adverse events reported against amicus lot: fa23g24065 or any fg lot that used the same lots of solutions (nacl or acda).The entire lot: (fa23g24065) of 2,058 kits was distributed to the american red cross as of 09/06/2023.Both haina and maricao flora recoveries were reviewed: haina: bacillus cereus was recovered four (4) times between january 2022 and august 2023.Two (2) of the times were in 2022, once in air and once in surface testing.The other two (2) times were in water tests in july 2023.This is a common bacteria found in both water and the environment.It is validated to be eliminated through the approved sterilization process.Maricao uses mixing room 2 and filling line 4 for all amicus solutions, including intersol.Bacillus cereus was recovered thirty-six (36) times between january 2022 and july 2023.This is a common bacteria found in both water and the environment.It is validated to be eliminated through the approved sterilization process.In july 2023, when the solutions for this lot were manufactured, bacillus cereus, was found 2 times.One of the recoveries was on the gown of an employee and one was associated to a bioburden spore count test.The recovery of the bioburden spore count test was investigated under a kabitrack event (1635338).It was found to be associated with contamination during the bioburden spore count process in the microbiology laboratory caused by the technician.Retraining of the technicians was a corrective action resulting from the investigation.The original platelet collection kit code: 4r2352, lot: fa23g24065 was not returned for evaluation.Fresenius kabi summary: based on complaint records, there are no additional adverse events reported against amicus lot: fa23g24065 or any fg lot that used the same lots of solutions (nacl, acda, and intersol).A review of haina flora showed that bacillus cereus was recovered 2 times in july 2023 (via water tests), however it is a common bacteria found in water and the environment and is eliminated through the sterilization process.A review of maricao flora showed that bacillus cereus was recovered 2 times in july 2023 when the lot of solutions was manufactured.One of the recoveries was investigated under kabitrack event 1635338 and found that the contamination occurred in the microbiology laboratory.The amicus disposable kit used in this procedure allowed for a double platelet product (2 bags) to be collected.The second (referred to as co-product) was transfused to a recipient with no reaction.As an additional note: cerus corporation submitted a medwatch (#: 3003925919-2023-00003) for the intercept platelet storage container that is used after amicus platelet storage and contains additional details of the investigation.According to cerus medwatch 3003925919-2023-00003: date of event: 24-oct-2023, date of their report: 01-dec-2023, cerus reported they received a spontaneous report of transfusion transmitted bacterial infection (ttbi) with an intercept treated platelet concentrate (pc) [transmission of an infectious agent via product] from the cerus chief medical officer (cmo).He was in communication with the medical director of transfusion services at (b)(6) center and relayed the information to cerus global product safety.The event of ttbi was associated with one of the two units of intercept platelets concentrate (pc) (din#: w20122385967000; implicated unit blood component processing set lot#: ce23e26l71; product code: e8342v00) manufactured from an apheresis collection of double platelets and double plasma.Each of the intercept pc were transfused to two different patients, one to the 73 y/o male patient at (b)(6) hospital who developed ttbi and the other to a patient at (b)(6) hospital without any issue.Reporter assessment: the reporter assessed the event as moderate in severity and serious due to hospitalization.Causality in relation to the intercept blood system for platelets device and to the transfused intercept pc was not reported.Cerus medical review assessment: the cerus medical reviewer assessed the event of ttbi associated with b.Cereus as serious due to hospitalization.Causality was assessed as possible to the transfused intercept pc at the time of this preliminary assessment since additional investigations are still ongoing.B.Cereus is a common spore-forming environmental contaminant that is resistant to full pathogen reduction treatment.Given that the implicated intercept pc was a day 4 product, it is possible that a small residual amount of b.Cereus, especially in spore form, may have proliferated after successful intercept pathogen reduction treatment.At this time, it is unclear if the b.Cereus in the implicated intercept pc was present pre or post-intercept treatment.Further analysis of the processing bag integrity and culture isolate gene sequencing must be completed to fully evaluate this adverse event.Although the patient's picc line and peripheral blood culture results are discordant, his clinical response during the transfusion was consistent with an acute septic reaction manifesting in fever and hypotension.The causality was assessed as possible in relation to the intercept blood system for platelets device at the time of this preliminary assessment since additional investigations are still ongoing.B.Cereus is a common environmental spore-forming organism that may be found on the skin.B.Cereus is effectively inactivated in the vegetative state but the spore form is known to be relatively resistant to the intercept process and this is stated in the manufacturers' instruction for use.Transmission of b.Cereus contaminated platelets is a rare but known complication, even when the intercept process is performed appropriately.The cerus medical reviewer considered the listedness for the event to be listed for transfused intercept pc and intercept blood system for platelets device based on applicable cerus safety reference information.

• Brand Name: AMICUS SEPARATOR SYSTEM
• Type of Device: AMICUS APHERESIS KIT
• Manufacturer (Section D): FENWAL INTERNATIONAL INC.; carretera sanchez km 18.5; parque industrial itabo zona f; haina, san cristobal, ; DR
• Manufacturer (Section G): FENWAL INTERNATIONAL INC.; carretera sanchez km 18.5; parque industrial itabo zona f; haina, san cristobal, ; DR
• Manufacturer Contact: rebecca mccandless ; 3 corporate drive; lake zurich, IL 60047 ; 8475502300
• MDR Report Key: 18278894
• MDR Text Key: 329891801
• Report Number: 3004548776-2023-00424
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK960005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/06/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 4R2352
• Device Lot Number: FA23G24065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2023
• 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): Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male